chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse practitioner via a company representative and refers to a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On an unspecified date in January 2019, the patient was vaccinated with GARDASIL 9 (dose, route, lot number and expiration date were not reported) for prophylaxis. On the same date of vaccination, the patient experienced an unspecified angioedema. The reporter also stated that, on the same date, the patient ate shrimp and she believed that the angioedema was related to the consumption of shrimp (food allergy). In addition, the patient was referred to an allergist, however, no treatment was given for the mentioned events and it was unknown if laboratory diagnostics or studies were performed. At the reporting time, the outcome of angioedema and food allergy was reported as recovered on an unknown date in January 2019. The reporter did not provide a causal relationship between the events and GARDASIL 9. Upon internal review, the event angioedema was considered to be medically significant.
Patient experienced redness, swelling and pain from the shoulder to the elbow in the arm vaccine was given. Lasted for about 4 days. Patient used APAP and BENADRYL.
Rash/hives, itching, fever, body aches Treating with Motion and Benadryl Fever and body aches resolved after 24 hrs Rash/hives and itching continue
Pt was being fed lunch, seemed fussy. Approx 30 minutes later developed twitching of one leg then the other. Pt brought to office after dad noted full body twitching and deviating eyes. The patient is a 6 month old male who was present with a complaint of seizures notes: patient brought into office by father at 1:13pm. While feeding him carrots at lunch patient did not seem to like them. He cried a little. Dad stopped feeding him and gave him a bottle instead. Approximately 1/2 hours later he started twitching. First it was one leg, then the other and then it was his arms. He called our office and a sick visit was made. Patient then progressed to his entire body twitching and eyes devlating. Dad put patient in the car and drove him to our office. Denies cyanosis or apnea. No hx trauma or choking. No fever. No URI sx. He received DTap, IPV, Prevnar, Flu, Hib and Rotavirus vaccines yesterday. Pt was in status upon arrival to our office. He was having a generalized tonicclonic seizure with eye deviation to the right. No cyanosis. Oxygen was applied immediately and 911 was called. Temp 100.9 Temporal, Pox 92%-99%, HR 140-160, RR 32-40. Accucheck 86. Pt given rectal Valium by EMS at 1:26pm. Pt developed perioral cyanosis, no apnea. PPV applied for approx 3 minutes and then free flow oxygen was used. IV attempted x 1. There was no change in seizure status. Pt place on stretcher and transported to the ER. Rectal Valium was given again prior to leaving the office (?time of administration). ER and Hospitalist were notified.  02/23/2009 MR received for 1/23-24/2009 with DX: Status epilepticus vs complicated febrile seizure. Pt initially presented to PCP in status epilepticus where EMS was called and transported. Temp 100.9 in office. Rectal Diastat x 2.  Seizing ~1hr with lip cyanosis. Seizure resolved on arrival. Temp 101.4. Pt in sinus tach.  PE (+) for being initially unresponsive to touch, later sleepy with decreased tone.
Large (10cm x 10cm) deeply pink, almost urticarial swelling over the left deltoid, extending to the shoulder.
pt recv vax & 3 days post vax pt exp hives;pt hives were treated w/DPH & resolved;
The first reaction was the first 24hrs which was just fatigue which is a "normal" event I guess. Then on the 25th of March I noticed some tiredness as well, no big deal. It wasn't until about April 9/10th 2021 I noticed problems sleeping. I cannot get to sleep and stay asleep and that has progressively gotten worse. I have tried taking over the counter medications and asked my DR if she could prescribe me something to help me sleep. I first talked to the nurse and then I went in and saw the DR on 6/2/2021 and 6/29/2021. Actually first, the over the counter sleep medications didn't help and I ended up going to the ER to see if they could help me figured this out. I went to the ER twice actually. I went on 4/26/2021 at The Hospital and I think the 4/27/2021. They gave me medication to try to get me to sleep but it was not working. Haldol and Ativan were the medications.
3 minutes post vaccination, patient had a vasovagal reaction while picking out a sticker. Child fell backwards and may have hit his head. The child regained consciousness immediately but was pale/irritable x5-10 minutes while placed in recumbent position w/ feet elevated. Child had no residual or additional symptoms- patient was evaluated by pediatrician and released.
Sore Arm, itching on spot of Inj, headache , sore throat, chills, body ache, feeling  very weak. Still have headache not as severe and weakness a little less but still have all symptoms except chills.
Swelling @ rt thigh site on 29MAR91; 3APR91 leg had knot; To Hlth Ctr leg hard to touch & small amount of peeling in center;
C/O patient had shot on Friday and last night she was screaming and shaking her head like a convulsion.  She did it twice.  Mom wants to know if that's a reaction of the (imm).
Caller reported two high schoolers dropped dead from the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "Caller reported two high schoolers dropped dead from the vaccine". The patient date of death was unknown. The reported cause of death was "Caller reported two high schoolers dropped dead from the vaccine".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200280341 same reporter/product/event, different patient; Reported Cause(s) of Death: Caller reported two high schoolers dropped dead from the vaccine
pt recv vax & devel reverse GBS & optic neuritis (eventually leading to blindness in one eye) following the vax;
Erythematous induration area at the injection site on (R) thigh. Treated with BENEDRYL/ KEFLEX.
Patient began to experience chronic indigestion, stomach pain and acid reflux within one week after of their first dose of COVID vaccine. Patient has been taking OTC medication at the prescription of her doctor
The first day I had fever and aches with fatigue and a headache. That lasted for 24hrs. I took PAXLOVID for 5 days. Because I didn't have enough COVID-19 tests after I finished with PAXLOVID I self tested and was positive and continued to for a total of 3 weeks. I'm not sure if I tested negative at one point and then rebounded. I had a rollercoaster ride of symptoms that was primarily congestion, runny nose and a cough which came and went. I continue to have a little bit of a cough today which is unusual for me because I don't have allergies.
From initial information received on 01/06/04 from another manufacturer (report # A0438871A) regarding an adverse event occurring in the USA, it was initially reported by a RN that an 18 month old male pt received his fourth dose of INFANRIX, Lot # DTPA599A9 in his left thigh and a dose of IPOL, Lot # not reported, on 11/04/03. Two days post vaccination, on 11/06/03, the pt experienced cellulitis and an injection site reaction characterized by redness and swelling. The pt was seen in a physician's office and treated with an unspecified antibiotic. As of 11/06/03, the events were unresolved. The nurse considered the events to be probably related to vaccination with INFANRIX.  From additional information received on 04/12/04, it was reported, "Reviewed, no additional information at this time".  No further information is anticipated, this case is considered closed."
Patient came to clinic with nausea, vomiting and achiness. Patient reported that her symptoms began 2 hours after receiving the Shingrix vaccine at her primary care physician office.
Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of MMR II on an unspecified date. Subsequently the patient had an unspecified reaction to MMR II. No further information is available.
Initial unsolicited report received from other health care professional (office staff) on 23-SEP-2016. This case involves a patient of unknown age and gender who was vaccinated with a dose of (FLUZONE HIGH DOSE (batch number: UI679AB, expiration date, dose and dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination the patient had vertigo. Lab data and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
No adverse event; Patient received a dose of VAQTA on 01-JAN-2021 and it had expired on 06-JAN-2021; This spontaneous report was received from an other reporter regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On 07-JAN-2021, the patient was vaccinated with a dose of Hepatitis A Vaccine, Inactivated (VAQTA) one dose, 0.5 milliliter, lot number: T001419, expiration date: 06-JAN-2021 (route of administration was not reported), and it was a expired dose (Expired product administered). The Hepatitis A Vaccine, Inactivated (VAQTA) had never undergone a temperature excursion. No adverse event reported.
Got an allergic rash itchy hives all over my body 3 days later.; Got an allergic rash itchy hives all over my body 3 days later.; Got an allergic rash itchy hives all over my body 3 days later.; Got mild fever; chills; body pains the next day after taking 1st dose of vaccine; This is a spontaneous report from a contactable consumer (patient) via regulatory authority. This 30-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) on 02Apr2021 at 16:30 (at the age of 30-years-old) via an unspecified route of administration as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination the patient did not have COVID-19 and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported she experienced mild fever, chills, and body pains the next day after taking the first dose of the vaccine; and an allergic rash and itchy hives all over her body 3 days later on 05Apr2021 at 14:00. The events required a doctor or other healthcare professional visit and the patient reported treatment with prednisone and dexamethasone 4 mg shot. The clinical outcomes of the events were recovering. Since vaccination the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Pt states around 1830-1900 she began shaking and was very chilled, throat started to swell and she had diff. breathing . She states she took 2 TYLENOL and within an hour felt better. No c/o cough or tongue swelling. States she did have headache.
Lost appetite, felt very weak and tired and had a fever of 101. Fever went up to 102 by evening and stayed at 102 for the next 24 hours. I contacted doctor's office twice and told them that I felt I had had a reaction to the shot. They told me that it must be something else that already existed when I came in. They asked me to come back in on 9/16/2010 ...I did. They did additional blood work and an ekg. The blood work showed that my electrolytes were a mess and I had a slightly elevated white blood cell count. They gave me Zithromax 250mill to take 2 the first day and one each day after for four more days. They also told me to take Tylenol for the fever.  I took the meds and stayed in bed. I continued to have fever and take Tylenol. I felt better but still weak on Sat. (they had me back in on Sat. for another blood work) Saturday evening my fever went up to 104 with no other symptoms. It was 104 for 14 hours along with severe chills. I finally was able to get it down to 101 and I put a call in to the doctor. This was on Sunday 9/19/2010. He told me not to take any more Tylenol and if the fever went back up to go to the emergency room. The fever gradually went back up to 104.2 and I arrived at the emergency room at 5:30 AM on Monday 9/20/2010. I have been until now..Wed. 9/22/2010 and am still waiting for some of the test results. They have not yet been able to determine what has caused my fever.
Information has been received from an unknown reporter concerning a 65 year old male patient who was vaccinated on an unspecified date with a intramuscularly dose of ZOSTAVAX (Merck) (Lot #: not reported). On 30-APR-2010, after receiving the ZOSTAVAX (Merck), the patient began breaking out in different areas of his body. The patient's caller stated that "is not sure if it is actual shingles or just a rash. It was extremely itchy, but goes away in 10 minutes after it appears". At the time of the report the patient was not recovered from shingles or rash, but recovering from itching. The patient also was vaccinated by intramuscular route instead of subcutaneous route. No adverse event were reported. Patient sought unspecified medical attention. Additional information is not expected.
Received Pfizer 2nd dose on 3/28/21 --chills, body aches, in bed for 2 days straight --body aches resolved after 6 weeks (began after first shot) --chills began after 2nd shot and resolved after about 2 weeks --no fever Now sleeping 10 hours/night Fatigue is gradually improving but still --interfering with her ability to function --feels different from fatigue related to Parsonage and depression  Treated for staph infection of left axilla on 4/13 that began a week before (a week after 2nd Covid-19 vaccine)
The patient received their booster dose at 1510. Starting at 1515 the patient reported that they were feeling light-headed. Roughly 30 seconds after the patient reported feeling light-headed the patient fell to the ground. I took the patients vital signs. At the time of the event the patient was bradycardic (HR=54bpm), tachypneic (23 rpm), hypotensive (100/80), they were sweating, and reported tingling in their hands. Oxygen saturation remained between 98-99 throughout the event. I instructed the patient to breath in through their nose, and out through their mouth using a count of 4. After 20 minutes the patient reported they were no longer experiencing previous symptoms and vital signs returned to normal. After being observed for an additional 30  minutes the patient remained stable.
About 2 hours after I received the shot, I started feeling tired and a warm sensation on my face. The following days I was feeling light-headed and on 01/17/10 about 10:00 PM I became extremely dizzy and I was rushed to the emergency room at Hospital. The doctor diagnosed me with Vertigo. I never had that before. After that I've been feeling tired till this day.
pt recv vax 17DEC96 & the next morning had severe pain, lt upper arm & shoulder;could barely move the arm for a while;used hot & cold compresses along w/APAP;have some relief but when lifting & moving arm about will have cont pain;
crying episodes last noc possibly shaking episodes last 2 days-of legs x 1min off & on last 2 days; better now;
heart attack; Information has been received from a lawyer, regarding a case in litigation and concerning a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On an unspecified date in or around January 2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving the suspect vaccine, the pt suffered a heart attack. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses, the loss of accumulations, and other economic and non-economic damages. The outcome of the event of heart attack was considered to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of heart attack was considered to be disabling.  Upon internal review, the event of heart attack was determined to be medically significant.
pt recvd vax;3 days later,infant stopped sleeping during the day;starting having blood in bowel movements & had some weight loss;MD told mom not rxn to vax;metabolic studies were nl;mom stated pt had also some high pitched cries;
Pt is 64 years old and I accidentally administered an HD flu shot for pts 65 years and older. Pt has not experienced any adverse reaction thus far.
pt recv anthrax/meningococal/influenza vax 10-14-99. 10-15-99 at 6:00pm exp hives upper/lower extremities. seen at hosp er, treated with Hydroxyzine 1.4 tabs every 6 hrs also Methylpred.
This spontaneous report as received from a consumer refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-APR-2018, the patient was vaccinated with VARIVAX. Other suspect therapies included sterile diluent. On an unknown date in April 2018, the patient experienced rash pruritic. The outcome of rash pruritic was reported as recovering/resolving. The reporter considered rash pruritic to be related to sterile diluent and VARIVAX.
Teen presented 3/18 with facial weakness, diplopia, and tingly progressed with a descending weakness areflexia felt consistent with Miller Fisher syndrome - a Guillain Barre variant. Received IVIG x 5 days with improvement in facial palsies, but persistent weakness, sensory changes.
Itchy skin with hives all over body, peri-orbital edema, SOB.
I received the first dose of Moderna's RNA vaccine on 12/31/21. The weekend following the vaccine, I experienced tachycardia. I had shortness of breath and my heart rate was very fast. It took a few days before my heart rate settled down. After the second vaccine, on January 28, 2021, I again experienced side effects. The day after my second vaccine, I initially had a fever, chills, and muscle aches. A few days later, I experienced tachycardia. It took a few days for my heart to normalize.   I am a teacher at a hospital. I had 3 cases of exposure in my classroom from August 27-September 10. On the evening of Sept 2, I again experienced tachycardia. On September 3, my heart was highly elevated. I had a rapid heartbeat and shortness of breath. My heart was fluttery, and it was difficult to get my heart rate back to normal. I experienced these symptoms from 9/2/21-9/18/21. I left work on Tuesday, 9/14/21 due to the severity of the condition and I had a COVID test. The test was negative. Recent bloodwork showed a low WBC. An antibody test was ordered, but I have not yet gone in for the test. I have been resting as much as possible, and my heart rate seems to have normalized again. I have not had a problem with my heart since 9/18/21. Today is 9/22/21.
extreme dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extreme dizziness) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Scoliosis, Neurological disorder NOS, Dystonia, Anemia, Sulfonamide allergy, Allergy to antibiotic, Drug allergy (most oral antifungals) and Drug allergy (muscle relaxant: Baclofen).    On 01-Jan-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 DIZZINESS (extreme dizziness). At the time of the report, DIZZINESS (extreme dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-302183, MOD-2021-302231 (Patient Link).
This case was reported by a nurse and described the occurrence of incorrect storage in a patient who received BOOSTRIX (batch number 3P9CL, expiry date 15th April 2016) and (batch number HM4FY, expiry date 6th December 2016). On an unknown date, the patient reecived BOOSTRIX. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: Nurse at this time did not have any other information. 10 patients received BOOSTRIX that was exposed to temperature of 30.4F Two lot numbers 3P9CL exp 4/15/2016 HM4FY exp 12/6/2016. This case is one of the 10 cases reported by the same reporter for the same vaccine.
Information has been received from a physician concerning a 16 week female patient who on 02-DEC-2009 was vaccinated with a dose of PNEUMOVAX 23 (662785/1124X) instead of PREVNAR by human error. There was no adverse event reported. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
his arm hurt for a few days; This is a spontaneous report from a contactable consumer. This reporter reported at a male patient (her son) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date single dose for COVID-19 immunization. Medical history included ongoing rheumatoid arthritis. He got RA out of nowhere and had to change his diet completely and start the medicine about 2 years ago (at 40 years old). Concomitant drugs included tofacitinib citrate (XELJANZ) for rheumatoid arthritis. The patient's doctor told him to stop taking tofacitinib for a week before the vaccine and don't take it for a week after the shot. Additionally, he works 15-18 hour days which is also not good for his immune system. The patient got his first shot and felt great and got the second one and his arm hurt for a few days but that's it. The outcome of the event was unknown.  No follow up attempts are needed. Information for lot/batch number can not be obtained.