chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient fainted immediately after injecting Menveo. Was unconscious 5-10 seconds and while out shoulders started to twitch. After coming to patient was alert but very tired and complained of nausea and ringing in the ears.  These symptoms lasted approximately 5 minutes.  Patient was apparently back to normal after 5 minutes.
Irritation, golf ball sized swelling at injection site, pain in whole body, difficulty using arm, lethargy, brain fog
Trapezoidal raised rash on upper arm, 4 inches by 3 inches, 3 weeks after Moderns covid-19 vaccine
Immunization site formed a very large blister 3 days later and was warm to the touch. Patient was seen at a walk-in clinic and prescribed an antibiotic and a cream. It was the site of the FLUZONE HD shot.
Ankle pain bilaterallly, left hand/wrist pain, rt hand - back of hand had pain, swelling to rt hand
pt tested positive for COVID in rehab center on 7/22/2021; pt was found deceased in rehab center; per death certificate the causes of death were:  Failure to Thrive, Alzheimer's, Recent Coronavirus Infection; hx of falls, DM, Alzheimer's)
Reporter stated that he has received a total of 4 Pfizer Reporter stated that he has received a total of 4 Pfizer/he had Covid 8 weeks ago; Reporter stated that he has received a total of 4 Pfizer Reporter stated that he has received a total of 4 Pfizer/he had Covid 8 weeks ago; The initial case was missing the following minimum criteria (Other- Info not qualifying for AE reporting- Medical Information). Upon receipt of follow-up information on [19Oct2022], this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Reporter stated that he has received a total of 4 Pfizer Reporter stated that he has received a total of 4 Pfizer/he had Covid 8 weeks ago". Clinical course: He has received a total of 4 Pfizer Covid-19 vaccines- Dose 1, Dose 2, Dose 3 (1st booster) and Dose 4 (2nd booster). Reporter stated that he called Pfizer because he had Covid 8 weeks ago and wanted to know when he can get his 3rd booster shot (Dose 5) and was not reporting any adverse events. Reporter did not know where his vaccine card was and was not able to provide any dates or lot numbers for when he received the Pfizer Covid-19 vaccine Dose 1, Dose 2, Dose 3 (1st booster) and Dose 4 (2nd booster). Reporter did not provide any additional information.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a health professional certified medical assistant concerning a patient who in February 2007, was vaccinated with the first dose of GARDASIL vaccine (yeast) IM. In September 2007 was vaccinated with the second dose GARDASIL vaccine (yeast) IM. No adverse event was reported. Additional information has been requested.
improperly stored product administered; no adverse event; This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. 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 dose of improperly stored vaccines: measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 ml, lot T010651 exp. date: 22-SEP-2021 (formulation, frequency and route of administration were not reported) as a prophylaxis. Administered dose of vaccine experienced the temperature excursion of 22.8 degrees Fahrenheit for 13 hour and 25 minutes. Data logger was involved. There was a previous excursion reported: 17.4 degrees Fahrenheit  for 31 minutes and 30 seconds..
Red stripe on arm, approximately 4" long and 2" wide, showed up sometime between 2/22/21 (not noticed after morning shower) and 2/23/21 7:30am (noticed after morning shower). Smooth and not hot to touch. Slightly itchy.
Warmth, redness and swelling on right deltoid.  No rash spreading beyond shoulder.  Minimal tenderness to touch.  Strength, ROM, and sensation intact.  No swelling of lips or tongue.  No difficulty breathing.
This literature report (initial receipt 17-Sep-2013) concerns a 67 year old female. On an unspecified date, the patient received an influenza vaccination (manufacturer and batch number not specified). On an unspecified date 12 days after receiving the influenza vaccine, the patient developed a relapse of AAV (Antineutrophil Cytoplasmic Antibody Vasculitis). The disease type was GPA (granulomatosis with polyangiitis). The ANCA (Antineutrophil cytoplasmic antibody) type was c/PR3 (cytoplasmic proteinase 3). Organs involved included kidney and lung. Treatment included cyclophosphamide (CYC) and prednisone (P). The outcome was not reported (The patient achieved disease remission).
Suspected vaccination failure/I had the shots and got it on shoulder, arm and down back; Got it on shoulder, arm and down back; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 15-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the shots and got them anyway on his/her left shoulder and arm and down his/her back.  The patient agreed that it was the worst. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This case was reported by a physician and described the occurrence of an injection site reaction in a male pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine. On an unspecified date, the pt received a SC dose of this vaccine. The recommended route of administration for this vaccine is IM. At an unspecified time, post/vax, the pt experienced an injection site reaction. The pt was seen at a physician's office. The injection site reaction resolved on an unspecified date.
Immunization on 4/25/16. On 4/26/16 right deltoid redness. Hives surrounding left eye, right upper forehead, right nasal bridge, in front and behind right ear. Treatment antihistamine.
First Dose: Nausea; First Dose: Diarrhea; First Dose: Tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Feb2021 09:00 (Lot number: EM9810) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (ongoing), notes: Had 10-15 years; "degenerative arthritis" (ongoing), notes: Diagnosed 2010; "Rheumatoid arthritis" (ongoing), notes: Diagnosed around 2015; "pneumonia", start date: Sep2020 (unspecified if ongoing). Concomitant medication(s) included: HUMIRA (ongoing); METHOTREXATE (ongoing); HYDROCODONE taken for pain (ongoing). The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "First Dose: Nausea"; DIARRHOEA (non-serious), outcome "unknown", described as "First Dose: Diarrhea"; FATIGUE (non-serious), outcome "unknown", described as "First Dose: Tired". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Patient reported malaise the night following the injection, then soreness, redness and a little knot at the site of injection, which started several days after. Shot was administered on 4/25/16, the arm symptoms began 5/1/16.
39 y/o Brazilian female c/o nausea, dizziness, and "don't feel good" 12 mins after receiving the 2nd dose of the vaccine. She was assessed and monitored by NP, EMT, and paramedic. She was diaphoretic and weak, BP - 133/89, HR - 76, resp - 14, O2 sat 98% on RA. She was placed on stretcher to lie down, cold wash cloth place on forehead, given H2O and barf bag. She did not vomit. She was kept at site until she reported that she felt better and had no complaints. She was given the Vaccination information sheet, reinforced instructions on ADRs/ SEs to call 911and go to the ED, follow up with her PCP, and registered. She verbalized understanding and willingness to comply. She denied any medical hx. She left site in no acute distress, strong, awake, alert, oriented to person, place, time and situation, skin warm and dry. Husband will be driving her home per pt.
Seizures, rushed to the hospital, intubated, MRI, catscan, spinal tap, EEG, bloodwork.  No fever.  Dr stated respiratory system was failing. Neurologist stated that she has patients die from these types of seizures.  CO2 gas in blood was 118 upon arrival.
flublok administered to 12 years old with no reported adverse event; Initial information received on 18-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to case 2022SA432188(CLUSTER).  This case involves a 12 years old male patient to whom vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK] administered with no reported adverse event.   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.  On 15-Oct-2022 the patient developed a non-serious event of flublok administered (dose: 0.5ml, route: intramuscular in the left arm, batch number: UJ893AA and expiry date: 09-Jun-2023) to 12 years old with no reported adverse event (off label use) for Immunization (Latency: same day) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken : not applicable.  Outcome: Unknown
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Malaise - within hours of vaccination, gradual onset, lasted ~36 hours Chills and low-grade fever - around 12:45 AM on 1/14/2021, resolved after 4 hrs with ibuprofen Chills and low-grade fever - another episode around 6:30 PM on 1/14/2021, resolved with ibuprofen (unclear duration since I was asleep)
Starting about 12 hours after I received the shot, I got body aches, followed by severe fatigue, then a few hours later I developed a fever- which got to 101.6 at its highest. I had a headache while I had the fever too. I took acetaminophen for the symptoms, which did help. These symptoms lasted almost exactly 24 hours, with the exception of the fatigue and body aches.   Today is one week since getting the second Pfizer shot, and the fatigue is still severe and the body aches are still present. Both are disrupting my ability to function at my job.
Erythema multiforme and urticarial rash from the torso, spreading to the face and legs. Was seen by physician office on 5/3/17. Sent home on BENADRYL. Went to the ED because mother was worried about rash spreading, sent home and diagnosed with viral exanthem. Sent home on BENADRYL. Seen again on 5/5/17. Despite rash now spreading to face, pt was well-appearing with nonpruritic multiforme rash.
Constipation; Nausea; Peeing a lot and that is worse; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipation), POLLAKIURIA (Peeing a lot and that is worse) and NAUSEA (Nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hip replacement on 28-Jun-2021.    On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced POLLAKIURIA (Peeing a lot and that is worse). On 26-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NAUSEA (Nausea). On 27-Jul-2021, the patient experienced CONSTIPATION (Constipation). At the time of the report, CONSTIPATION (Constipation) outcome was unknown and POLLAKIURIA (Peeing a lot and that is worse) and NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Patient reported that he was on medications since hip replacement that could cause a bladder infection.  No treatment details were reported.
TENIVAC was administered post expiration with no reported adverse event; Initial information received on 08-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] was administered post expiration with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation (expired product administered) (unknown latency).  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.   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 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.
Within a few minutes of getting (MMR, IPV and VARIVAX) immunization, patient began coughing, flushed from head to toe then eyes red, nasal congestion.  Benadryl 1 1/2 tsp given.  Coughing increased, nasal congestion increased, scratching head vigorously.  Paramedics called.  Taken to ER.  08/18/2008 MR received for DOS 6/26-27/2008 with D/C DX: Anaphylaxis.  pt presented by ambulance from PCPs office after receiving vaccines. Pt developed lip swelling, rash, cough, congestion and itching within 1 minute of receiving MMR. Pt was walking and became limp and slumped over. Pt wheezing per parent.  Given Epi and Benadryl in office. In ER pt had mildly erythematous throat, erytema of cheeks, chin and ears. Vomited x 1 in ER.  Given albuterol neb, Solumedrol and Zantac IV. Quickly weaned to room air. No further event o/n and d/c home.
pt recv vax & reported exp a high sensation where felt a rush of energy w/in 1-2hr p/vax which lasted 2hr
Left arm (shoulder to elbow on outer portion) warm to touch, red, swollen, painful, itchy. Started 4/6/06 at 7:30pm no improvement as of 3:30pm on 4/7/06 (no treatment yet).
It started with a quarter size redness, swelling, and itching. By the third day the swelling and itching went away. Seven days later, I woke up with itching, redness and swelling grown 20mm, the bump feels hard.
Information has been received from a mother of a 14 year old female who n 04-MAR-2008 was vaccinated IM with the first 0.5 mL dose of GARDASIL (lot # not reported). There was no concomitant medication. On 04-MAR-2008 the patient experienced coldness in her head, syncope, dizziness and pallor after receiving vaccination. Subsequently, the patient recovered from coldness in her head, syncope, dizziness and pallor after 15 minutes. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 4/7/2008.  Follow up information was received.  A licensed practical nurse reported taht the patient, a white female with no known medical history who on 04-MAR-2008 was vaccinated IM in the right deltoid with the first dose of GARDASIL (lot # 655670/14590).  On 04-MAR-2008 the patient felt "cold" inside her head.  The symptom lasted about 10 minutes (previously reported as 15 minutes).  The patient recovered the same day.  No further information is expected.
Redness at injection site, itchy, subcutaneous nodule at injection site, warm at touch
Patient called 6/10 and stated on 5/27 he started feeling light headed and this continued through 6/1 when he went to the ER where they diagnosed him with a heart condition he was told was due to the vaccine. He  had a pacemaker implanted and is now doing well. He gave me no other details.
Hives on multiple areas of body. Pt taking Benadryl which appears to be working. Will f/u tomorrow with patient. No SOB or angioedema.
5cm by 7cm indurated and erythematous area right shoulder. Treatment is to ice area.
Systemic: syncope, brady cardia, hypotension, feeling faint-Severe, Systemic: Hypotension-Severe
She lost part of her vision/Her vision is distorted; She is having issues with one of her eyes; This spontaneous case was reported by a consumer and describes the occurrence of EYE DISORDER (She is having issues with one of her eyes) and VISUAL IMPAIRMENT (She lost part of her vision/Her vision is distorted) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy, Drug allergy and Allergy (Other products.). Concomitant products included HYOSCYAMINE from 20-Feb-2021 to an unknown date for Ache stomach, AMLODIPINE BESYLATE from 10-Jan-2021 to an unknown date and BISOPROLOL FUMARATE (BISOPROLOL FUMERATE) from 10-Jan-2021 to an unknown date for Blood pressure management, FUROSEMIDE from 25-Mar-2021 to an unknown date for Diuretic effect, DESIPRAMINE from 18-Feb-2021 to an unknown date for Stomach ache.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EYE DISORDER (She is having issues with one of her eyes). On 25-Jun-2021, the patient experienced VISUAL IMPAIRMENT (She lost part of her vision/Her vision is distorted). On 25-Jun-2021, VISUAL IMPAIRMENT (She lost part of her vision/Her vision is distorted) had resolved. At the time of the report, EYE DISORDER (She is having issues with one of her eyes) had resolved. Not Provided          No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Patient demographics, dose one details, concomitant medications were added and dose 2 details and event details and outcome was updated.
Legs gave out and kept falling, severe back pain and leg pain. Pain pills that didn't help until LYRICA was given in hospital for nerve pain-2013.
Information has been received from a healthcare professional regarding a 33 year old patient of an unkonwn gender. On 31-MAR-2014, the patient received VAQTA dose that equal to two adult doses of VAQTA instead of intended one adult dose of VAQTA and one adult dose of Hepatitis B vaccine. Nurse gave two doses of pediatric, VAQTA (lot number J000985, exp 20-AUG-2015 for both vials( for total of 1 ml for an adult dose and intended to give an adult dose of Hepatitis B vaccine but inadvertently gave another adult dose of VAQTA (lot number reported as J014587, exp 15-JAN-2016) to patient. No adverse effects reported. Additional information has been requested.
Information has been received from a physician concerning a female patient in her 60's with previous history of shingles several times who on an unspecified date was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) (route and Lot # not reported). There was no concomitant medication. Since vaccination the patient had been developing shingles more frequently and more severely. On 07-APR-2011 the patient was seen in the physician's office with shingles located on her buttock. She received unspecified treatment. The patient was depressed and frustrated that she kept getting shingles. The patient was normally a healthy person with no history of cancer or immunosuppression. At the time of the report, the patient had not recovered. Additional information has been requested.
Forty minutes after administering Hepatitis B. Pt returned to clinic c/o pain in shoulder, radiating down left arm and into left elbow. Pt appeared frightened, hyperventilating. BP taken 130/80, site checked. Pt resting at clinic. BP improved. Breathing calmer, still c/o pain in left elbow. Pt left. Advised to call back if no improvement
2-24-21 at 6:30am; rash under the injection site, sore, slight swelling, hot to touch. size of an orange. possible swollen lymph nodes recommended antihistamine (benadryl, claritin, or zyrtec), ibuprofen for swelling. recommended drawing a circle around the affected area to see improvement/worsening size verbalized understanding