chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving the vaccines in the clinic room by student nurse supervised by nurse, Patient was asked "Are you feeling OK?" and replying "Yes." Patient was then escorted to the hallway to receive a copy of his immunization record. Nurse followed Patient out asking some insurance questions. Patient proceeded to text his mother and had a syncopal episode next to the visitors bathroom. He proceeded to fall backwards hitting his head on the door of the bathroom and slide to the floor. Ammonia stimulate was used and Patient aroused immediately. He sat up and was given a glass of water, nurse inspected the back of his head and neck, assessing no S&S of injury. Patient denied concerns. Patient was instructed to stay in the office for at least 15 min following the syncopal episode, but refused. Patient was accompanied by an uncle and was taken home. Patient denied dizziness, lightheadedness or injury to head or neck.
Upset stomach; Dizziness; Weakness; Tiredness; Nausea; Vomiting; This spontaneous report received from a consumer concerned an 80 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: prostate cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on JUN-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: enzalutamide (capsule, oral, batch number: 1739968 expiry: 28-FEB-2023) 160 mg, 1 time every 1 day from 19-JAN-2021 to JUN-2021 for prostate cancer.  Age at time of vaccination 80 years old. No concomitant medications were reported. On JUN-2021, the patient experienced upset stomach, dizziness, weakness, tiredness, nausea, and vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with enzalutamide was withdrawn on JUN-2021. The patient had not recovered from upset stomach, dizziness, weakness, tiredness, nausea, and vomiting. This report was non-serious.
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old patient who received 0.5 mL dose of vaccine ADACEL lot U5458BA, expiration date: 28-Sep-18 via intramuscular route in the right deltoid on 02-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included FLUZONE QUADRIVALENT for Immunisation. It was an actual medication error due to expired vaccine used. It was reported that patient received ADACEL that was three days expired. It was unknown whether patient experienced any adverse reaction after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
angioedema; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (angioedema) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANGIOEDEMA (angioedema) (seriousness criterion medically significant). At the time of the report, ANGIOEDEMA (angioedema) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.  redness and swelling on arm down to fingers.  Company comment; This spontaneous case concerns a male patient of an unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) event of Angioedema that occurred on an unknown date after receiving the mRNA-1273 vaccine on an unknown date. Patient reported redness and swelling on arm down to fingers. Clinical course and treatment details were not reported. The outcome of event was not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a male patient of an unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) event of Angioedema that occurred on an unknown date after receiving the mRNA-1273 vaccine on an unknown date. Patient reported redness and swelling on arm down to fingers. Clinical course and treatment details were not reported. The outcome of event was not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per medical judgement.
Information has been received on 5/27/03 regarding a case in litigation concerning a male minor child who "in or about 1997" received vaccinations containing the mercury-based preservative thimerosal. It was reported that "in or about 1997" the pt was vaccinated with hep B virus vaccine rHBsAg. The pt also receivec "in or about 1997" hep B vaccine recombinant (Engerix B), HIB conjugate vaccine (HibTiter). The pt also received "in or about 1997 and 1998" Trihibit. It was reported that allegedly through the thimerosal-containing vaccinations administered to the pt during the first several years of his life, he was poisoned by cumulative doses of mercury in the thimerosal. The alleged result of the mercury in the thimerosal-containing vaccinations received during these development years, the pt now suffers, and in the future will continue to suffer, from the toxic neurological effects of his mercury poisoning, including but not limited to autism. Upon internal review toxic neurological effects, mercury poisoning, and autism were considered to be other important medical events (OMIC). No further info is available.
Case previously recorded as MA2009-6295. Case received on 25 NOV 2009 via MedComfrom healthcare professional the following information: An unspecified number of children younger than 4 years was vaccinated i.m. with FLUVIRIN, batch no. unknown, on unknown dates. No events were reported. No further information available. MedCom no:NA09-008809.
Wheezing, skin hot, flushed, itching, rash, difficulty swallowing. 1 dose of Benadryl and 1 dose of epinephrine.
Numbness starting in right arm progressing to severe pain causing unconsciousness similar stroke/heart attack.  911 was called.  Full body tremors (not chills) developed shorty after making it difficult to walk and talk that progresses to severe pain in both arms.   Transported to ER.  Eventually tremors subsided and pain progressed to numbness and was discharged from ER.  "Bilateral arm pain Diagnosis management comments: 44yo F presenting with b/l forearm/hand tingling.  Patient's neurological exam had no focal deficits.  Patient is well-appearing.  His recent admission.  Patient had a cardiac echo which was unremarkable, EF was normal, 55-60% with no WMA. CTA head and neck was negative. CTA chest tonight was normal and CT head was normal. At this time, paitent is ok for dc home. I do not suspect a stroke as the cause of his bilateral upper extremity paresthesia - this could be due to peripheral neuropathy vs vaccine side effect. His syncope could be vasovagal given his hx. Vitals are normal. Plan is for dc home. Return precautions/fu instructions reviewed."
This spontaneous report as received from a registered nurse concerning unspecified number of patients of unknown age who on an unknown dates were vaccinated with doses of VAQTA (doses, routes and lot numbers not provided) that were exposed to 28F for an unknown period of time. No adverse symptoms were reported. Additional information has been requested.
I had someone in my family suffer an aneurysm after receiving the pfizer covid 19 vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), (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: ANEURYSM (non-serious), outcome "unknown", described as "I had someone in my family suffer an aneurysm after receiving the pfizer covid 19 vaccine". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial information received on 13Jun06 and 16Jun06 from a health care professional. A 17 yr old female pt had received a dose of Adacel, lot number C2341AA, in the arm on 07Dec05. The route and site of administration was not reported. One day later, the pt developed orbital pseudotumor. The pt was treated with high doses of corticosteroids and recovered. She again developed another orbital pseudotumor on 05Jun06 after receiving Tubersol on 24Apr06, and Menactra on 18Apr06, that event is reported in case 2006-01513.
This is a 63y.o. female with a history of asthma, diastolic CHF, nonischemic cardiomyopathy, HTN, type 2 DM, and COVID-19 infection who presents to the ED with RLQ pain that began this morning. She describes it as a sharp pain that does not radiate. She also admits to N/V but denies fevers, chills, constipation, diarrhea, hematochezia, or melena. She has never had a colonoscopy but has done Cologuard testing in the past. While in the ED, her SpO2 dropped to 88% on room air, so she was placed on 2 L nasal canula. She was on home oxygen after she had COVID-19 in April but has since been weaned off. She denies SOB, cough, or wheezing. She does admit to chronic BLE edema.
Moderna vaccine booster administered on 11/5/2021 with an expiration date of 10/11/2021. Inquiry submitted to Moderna requesting validation of vaccine potency. A response from Moderna is expected between 8-10 business days. Expiration date currently not printed on the vaccine vial or carton. Vaccine expiration date listed in the database lookup tool is 12/31/2069. Patient contacted on 12/4/2021 and 12/6/2021, unsuccessful attempts to contact patient.
Information has been received from a nurse practitioner (NP), via a company representative, concerning a 12 year old female patient, who on 28-OCT-2007 was vaccinated IM with the first dose and on 08-JAN-2008 with the second dose of Gardasil (lot # invalid dose 1; lot #658556/1060U dose 2).  On 08-JAN-2008, "within 24 hours" of receiving the second vaccination, the patient experienced nausea and a possible fever.  On 09-JAN-2008, she returned to the NP's office for evaluation, though she did not have a fever at that time.  Subsequently, the patient also recovered from nausea (duration not specified).  Additional information has been requested.
Patient scheduled himself for appointment for COVID-19 Immunization Dose 1 with Pfizer Primary Dose. Patient said he was here for his first covid vaccine dose 1 on 3/17/2023. On 4/7/23, the staff pharmacist had checked State Immunization Information System for all appointments that day and realized this patient who was due for his Dose 2 of Pfizer Primary Series Covid Vaccination had already received a COVID-19 Vaccine from Janssen on 11/29/2021. When we contacted the patient, he said he was in fact wanting to get primary series with Pfizer Covid Vaccine since he had lost his card and wanted to restart the series. Patient did not report any adverse effects or symptoms. We advised the patient repeating the primary dose is not required since they have already done so.
A rash started 12 hour after dose on inside of both bicepts, then next morning a rash under both arm pits, then following day a rash on both hips and butt. follow by a rash behind both knee's. Used  benadryl liquid, and cream. Rash now going on 4 days.
real sore lt arm w/red area 2" around site, hot to touch; stomachache, h/a started noon next day 30JUL & has cont, now has joint pain, elbows, knees; hot/cold flashes;
06/21 PM: Rashes / Hives from the scalp to the chest, including face, neck, upper back, arms, wrists and hands, red, patchy and very itchy Took Cetirizine Hydrochloride 10mg * 1 tablet 06/22 whole day: Rashes / Hives from the scalp to belly, red, patchy and very itchy Took Cetirizine Dihydrochloride 10mg * 1 tablet 06/23 whole day: Rashes / Hives from the scalp to thighs, red, patchy and very itchy 06/24 AM: Rashes / Hives all over the body, from face to legs, ankles and insteps, red, patchy and very itchy Took Zyrtec 10mg * 1 tablet
bedridden; cant pick up her arm; her neck is swelling like there is 2 balls growing on her neck; soreness; fever; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (bedridden), LIMB DISCOMFORT (cant pick up her arm), SWELLING (her neck is swelling like there is 2 balls growing on her neck), PAIN (soreness) and PYREXIA (fever) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced BEDRIDDEN (bedridden), LIMB DISCOMFORT (cant pick up her arm), SWELLING (her neck is swelling like there is 2 balls growing on her neck), PAIN (soreness) and PYREXIA (fever). At the time of the report, BEDRIDDEN (bedridden), LIMB DISCOMFORT (cant pick up her arm), SWELLING (her neck is swelling like there is 2 balls growing on her neck), PAIN (soreness) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment medications were provided
Sore, very swollen arm. Followed by large red rash. Hot to the touch.  Day 2 swollen, sore arm pit, large red area around injection site. Hot to the touch.  Swollen arm pit has gone down by day 3.  Red, hot rash still present as of day 6 of vaccine. Rash does get bright red at times.  I do have pictures of the site.  Between day 1 and day 6 rash has grown and is persistent.  I self medicate with Motrin and ice packs.
On 01/07/2023 I started with a cough and fatigue. I did a home test, and it was positive. I reached out to my provider over the phone and prescribed PAXLOVID. I was also told to stop taking certain medications while on PAXLOVID treatment. I then tested negative for COVID-19 on 01/16/2023. I felt better after treatment.
Burning and redness in both armpits, fever of 100.0 Fahrenheit, headache, fatigue.
Itching at site; stopped being sore 2 days after and then 7 days after became sore again
Became ill; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Became ill) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Became ill). At the time of the report, ILLNESS (Became ill) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided.
pt recvd vax & found dead in crib; autopsy pending, tentative dx: sids; pt was not a well baby; hospitalized shortly after birth;
Narrative:  SORENESS STILL THERE TODAY BUT IMPROVING Symptoms:  & SORENESS AT INJECTION SITE Treatment:
Initial and follow up information was received from a pharmacist concerning a patient (age and gender not reported) who on 12-SEP-2013, was vaccinated with a dose of VARIVAX (Lot No. H007608, exp. 29-MAR-2014) (dose and route not reported) which was exposed to 26F for 480 hours (also reported as 20 days). No adverse events were reported. This is one of several reports received from the same source. Additional information is not expected.
local rxn to flu vaccine requiring U.C visit 2d after flu shot administered. Tx'd by U.C. doctor & Amoxicllin
INCORRECT PRODUCT STORAGE; VACCINE WAS REFROZEN AND ADMINISTERED TO PATIENT; This spontaneous report received from a health care professional concerned a 53 year old female. 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, and batch number: 1821286 expiry: 20-MAR-2022) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. Age at time of vaccination 53 years old. No concomitant medications were reported. On 02-JUN-2021, the patient experienced vaccine was refrozen and administered to patient. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was refrozen and administered to patient and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220538890, 20220540611, 20220541180, 20220537683, 20220540524, 20220537341, 20220537356, 20220537444, 20220537532, 20220537548, 20220537688, 20220538146, 20220538210, 20220538238, 20220538292, 20220538297, 20220538316, 20220538347, 20220538379, 20220538411, 20220538425, 20220538428, 20220538437, 20220538480, 20220538573, 20220538627, 20220538666, 20220538693, 20220540324, 20220540435, 20220540536, 20220540570, 20220540814, 20220540816, 20220540853, 20220541085, 20220541401, 20220541506, 20220537507, 20220538480, 20220540420, 20220540765, 20220540642, 20220540474, 20220540324 and 20220539045.
Fever (100.2) and chills until today. Right arm sore and black & blue at injection point. Left upper arm very sensitive. Still slightly sensitive today.  Extreme fatigue.  Loss of appetite for 2 days.
Initial information received on 20-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a six-months-old female patient who received third dose of 0.5 mL ACT-HIB lot UI803AAA, Expiration Date on ACTHIB Powder: 21Sep2018 via intramuscular route in the left thigh on 20-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTARIX for Immunisation; PREVNAR 13 for Immunisation; PEDIARIX for Immunisation; and FLUZONE QUADRIVALENT for Immunisation. It was a case of actual medication error due to Expired vaccine used. It was reported that she gave an expired ACTHIB today. ACTHIB and Saline box Lot UI803AAA, Expiration Date: 01-Jul-2018, ACTHIB Powder Lot UI803AAA, Expiration Date on ACTHIB Powder: 21Sep2018. There were no side effects. 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. Documents held by sender: none.
Given DTAP/IPV/MMR on 08/01/2003-Around 4:00PM on 08/02/2003.  Mom noticed patient scratching right upper arm.  Had small red area at shot site.  On 08/13/2003 area up in size complained of aching and itching.  8x6.5 cm red, swollen area.  Right arm DTAP site Temperature 97F.
Whole body spams/jerk, not unlike what an infantile spasm looks like, followed by crying.  Five, single, independent episodes of one full body spasm/jerk over the course of 15 hours after the vaccine was administered.  They did not appear in a close cluster, but were spaced by variable time, even hours in between.  Two were observed by my husband while I was at work and he told me about them when I arrive home around 6:30pm.  Three more occurred through the evening and night, with the last at maybe 2am.  He also developed a high fever, with the highest recorded temp of 103.5 with an Exergen temporal thermometer.  Not sure when exactly the fever spiked, but I do not believe he had the highest fever reading until sometime after he had the first two episodes.  After the third episode, the first that I observed, I thought it might be a very short febrile seizure and called the on call doctor to ask whether to use an anti-pyretic.  Only later did I investigate further (I am a physician, but do not see peds) and realized that febrile seizures are generally ONE episode and not multiple (though looking back, the on-call doctor did imply that by saying if he had more we should go to the ER).  After more investigating and observing video of infantile seizures, the episodes appeared most like an infantile seizure, but not in close clusters.  He appeared ill consistent with the fever of a viral infection, possible flu, but no worse between the spasms.  Prior to the vaccination, his doctor and I had discussed whether or not to administer the vaccine, given the fever the few days before, but he was comfortable with doing it because patient's fever was below 100.0 and I agreed with his assessment.  In general, patient has been fine since.  He does appear a little "twitchy" at times, particularly when he is sleepy, but I cannot be sure whether that is new or something that we notice now because of being more attentive.  My husband has observed the twitching, as well.  I can honestly say that we never observed any "twitching" prior.  We probably should have gone to the ER, and the on call doctor did advise that if they continued, but since they were not getting longer or more frequent, we decided to wait and see and he stopped having them by morning.
Information has been received from a physician concerning a male pt who on 10/2/00 was vaccinated with pneumococcal vaccine 23 polyvalent. Subsequently, the pt experienced injection site swelling in the arm and a "low grade" temperature for approx. 4-5 days. Steroids were administered. Unspecified medical attention was sought. No further information is available.
Information has been received from a health professional concerning a 16 year old female with no medical history who on 06-FEB-2007 was vaccinated IM in to the right deltoid with a 0.5 ml dose of Gardasil (yeast) (lot # 654535/0960F). There was no concomitant medication. On 06-FEB-2007 after vaccination the patient developed a local reaction. She experienced 30 seconds of dizziness. The local reaction started with pain at the injection site that radiated down her arm and her entire arm was red. After the patient subsided the arm went numb and then the patient was fine. The entire episode lasted only 5 minutes and the patient seemed fully recovered. Additional information is not expected.
Nearly complete hearing loss in right ear, retaining some hearing through the cranial bones.  This occurred approximately  5-15 days after the second dose.  It was hard to say when as I was alone in the house and did not interact with others.  I first noticed a problem when I had to turn the car radio up louder and had difficulty hearing my guitar when played.
Information has been received from a Hepatitis A virus vaccine inactivated (manufacturer unknown). Subsequently, the patient had a seizure. Upon internal review, seizure was considered to be an other important medical event.  Additional information has been requested.