chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from nurse practitioner concerning a healthy 28 month old black male pt with no known allergies and a history of one episode of reactive airway disease at 34 weeks of age who on 21May2002 was vaccinated with a dose of varicella virus vaccine live. Concomitant medication on 21May2003 included a third IM dose in the left thigh of hep B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC), a first SC dose in the right arm of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)  and a third SC dose in the left arm of poliovirus vaccine inactivated. The pt had no adverse events following prior vaccinations. On 16Oct2003, the pt developed varicella. The pt presented to the medical office with approximately five to seven vesicular lesions. The pt was afebrile, eating well and in no apparent distress. The pt was treated with diphenhydramine hydrochloride (Benadryl Elixir), calamine lotion and acetaminophen (Tylenol). The pt had a varicella titer during the week and the results were pending. There were no other laboratory tests. Subsequently, the pt recovered. The reporter noted that the pt's two sisters had not experienced symptoms. A product quality complaint was not involved. The reporter also mentioned that the pt's two older brother's developed more symptomatic varicella illness post vaccination with varicella virus vaccine live. Additional information is not expected.
a lot of congestion; dizziness; trouble breathing; fever of 101.5 F; really bad chills; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (a lot of congestion), DIZZINESS (dizziness), DYSPNOEA (trouble breathing), PYREXIA (fever of 101.5 F) and CHILLS (really bad chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced NASAL CONGESTION (a lot of congestion), DIZZINESS (dizziness), DYSPNOEA (trouble breathing), PYREXIA (fever of 101.5 F), CHILLS (really bad chills) and HEADACHE (bad headache). At the time of the report, NASAL CONGESTION (a lot of congestion), DIZZINESS (dizziness), DYSPNOEA (trouble breathing), PYREXIA (fever of 101.5 F), CHILLS (really bad chills) and HEADACHE (bad headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant details were provided No treatment details were provided
A non-serious spontaneous report of "child moved and we squirted some in his eyes" was received from a non-health care professional concerning an 11-year-old male subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. On 07-Oct-2009, the patient received FLUMIST. During the FLUMIST administration, the patient moved, and some of the vaccine was squirted in his eye. The patient's eye was rinsed out with water. The patient stated that he "never had any problems." There was no adverse event associated with this medication error; therefore, treatment and reported/sponsor causality assessment are not applicable, and the event is considered resolved.
Fever chills, body aches Narrative: states: woke up around 1am with fever, chills, and body aches. awoke at 5am and 7am drenched in sweat. experienced fatigue and body aches  throughout even 2 days post vaccination and had bad night sweats the second night as well.
First shot - sore upper arm causing limited mobility, slight fever (99.7F) for 5 consecutive days.  Second shot: sore upper arm causing limited mobility, fever (100.4F) for 36 hours, body pain, fatigue.
Pt stated that 2 days after receiving 1st Japanese Encephalitis vaccine, she developed dizziness, fever, throat discomfort, "swollen glands". Symptoms have since resolved. Further doses of JE deferred.
Patient returned to clinic approximately 30 minutes after immunization with hives on face, neck, trunk and extremities.
A minute after the client was vaccinated, she lost consciousness. Fell and hit her head on the floor. She became responsive. Minutes after, she became hot and visibly sweaty. Ambulance called. EMS services declined. Client went home with father and according to the clients father, the client appeared "her normal self."
This spontaneous report was received from a physician assistant via company representative regarding a male patient of unknown age. Information on the concurrent conditions and medical history of the patient were not reported. On an unknown date, varicella titers were run on the patient which demonstrated the patient had no evidence of ever having chicken pox. On unknown date, the patient was then administered a dose (dose 1) of VARIVAX (lot, expiration date, route and anatomical location were not specified) and on an unknown date later, patient was administered a second dose of VARIVAX (lot, expiration date, route and anatomical location were not specified). Concomitant medication were not reported. On an unknown date after vaccination, the varicella titers were run again and the patient demonstrated negative seroconversion. Outcome of the event was unknown at the time of report. There was no Product Quality Complaint (PQC) involved. Relatedness of the event with VARIVAX was not reported. Additional information has been requested.
Acute noon-ST elevation myocardial infarction CAD (cororary artery disease  Bypass Graft Coronary Artery (None) (08-05-2021
received the flu shot and 4 days later he got the flu; Initial information received on 07-Nov-2020 regarding an unsolicited valid non-serious case from a non-healthcare professional (patient father).  This case involves adult male patient with an unknown age who had received the flu shot and 4 days later he got the flu (influenza), while he received vaccine influenza quadrival a-b intradermal vaccine [Fluzone].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication details were unknown.   On an unknown date, the patient received the patient received influenza quadrival a-b intradermal vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, 4 days after starting the suspect vaccine therapy, the patient had the flu (influenza).  No laboratory data was reported. It was not reported if the patient received any corrective treatment. At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case. No further relevant information was reported.
Ringing ears, Cough, congestion, sneezing, runny nose, head ache, blood in mucus, loss of taste and smell,
This spontaneous report as received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On 10-JUL-2016 to 09-SEP-2016 the patients were vaccinated with improperly stored VAQTA (dosing details were not reported) lot # L036300, expiry date: 04-NOV-2016, which was stored at temperature of 25 degree Fahrenheit, for a time frame of 4 days 1 hour 45 minutes there was no previous temperature excursions reported, (lot # M002268, expiry date: 20-SEP-2017), which was stored at temperature of 25 degree Fahrenheit for a time frame of 15 minutes. No adverse effects reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
12-26-13: Mother of client called HD to report that patient was lethargic with a red blotchy face and was shivering uncontrollably. She was instructed to go to the ER. F/U call on 12-30-13 when mother stated patient had the above mentioned symptoms and fever of 101 degrees F through the night but all symptoms cleared by the next morning on 12-27-13. She did not go to the ER.
Pain, swelling - site admin. one inch from bend. Pain and burning on adm. at approximately 4:15p. Swelling and pain upper arm 1-2 hrs later. Severe pain with movement. Iced. Acetaminophen 1000mg.
No adverse event. The vaccine administered on 3/28/22 expired on 3/17/22. Moderna tested the stability of the same lot number and determined that the dose given was still protective against the Covid-19 virus.
Beginning at 2:45 AM my arm was painful and swollen. I woke up and my head started throbbing. then nausea developed, chills, fever going from 99-102.6. Muscle and joint aches are terrible. I have been so sick all day and it is 10:00 PM. No relief in sight. Poor appetite. Dry skin. Gas. I missed work and have been in bed all day. I will will miss work tomorrow too. This is awful.
COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID-19) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) on 29-Mar-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive. Patient's age was reported as over 65. Concomitant medications details were not reported.  The reporter wife of the patient who was reporting for her husband. The patient tested positive with rapid test immediately, that showed very red and was very clear that patient was positive. Patient also  had a headache. They done the Rapid BINAX test after attending the wedding and patient was immediately positive. The patient received all of the doses which were Moderna. Reporter does not have their vaccination cards handy to provide lot, or expiration date. The doctor prescribed medication Paxlovid.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in. This case was linked to MOD-2022-619098 (Patient Link).
down with a bad cold; Runny nose; Sinus pressure; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (down with a bad cold), RHINORRHOEA (Runny nose) and PARANASAL SINUS DISCOMFORT (Sinus pressure) 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (down with a bad cold), RHINORRHOEA (Runny nose) and PARANASAL SINUS DISCOMFORT (Sinus pressure). At the time of the report, NASOPHARYNGITIS (down with a bad cold), RHINORRHOEA (Runny nose) and PARANASAL SINUS DISCOMFORT (Sinus pressure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient is scheduling for second dose.  No concomitant medications were reported. No treatment information was provided.
Redness, warmth, elevation 30mm appearing within 24 hours and disappearing 48 hours later.
Hot itchy rash about the size of her hand on arm; Soreness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Hot itchy rash about the size of her hand on arm), PAIN (Soreness) and FATIGUE (Fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced RASH PRURITIC (Hot itchy rash about the size of her hand on arm), PAIN (Soreness) and FATIGUE (Fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH RELIEF) at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; ARNICA EXTRACT at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Hot itchy rash about the size of her hand on arm), PAIN (Soreness) and FATIGUE (Fatigue) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No relevant concomitant medications were reported.  Treatment details included Benadryl cream, Benadryl tablet, Ice, Arnica topical gel and Tylenol.
Right upper arm with 2 by 5 cm area of erythema surrounding injection site.  PREDNISONE 9pak) 10 mg 6-D pak was given.
PATIENT IDENTIFIED AS BEING 12 YEAR, HOWEVER DATE OF BIRTH REFLECTED THAT HE WAS 11YEARS AND 11MONTHS OLD. PATIENT WAS GIVEN ADULT DOS E OF PFIZER .3ML.
Pt called pharmacy roughly 20 minutes following first Pfizer vaccine from restaurant after leaving Pharmacy. He reported sudden onset of ocular pressure and headache with muscle pain around the injection site. RPh discussed with patient that there were no issues during the 15-minute monitoring period post vaccination. Negative for difficulty breathing, hives, itching, other anaphylactic response. Injection site reaction sounds normal, reports pain around injection site. Pt informed that HA is a possible side effect and tylenol or motrin could be taken. Advised that if symptoms worsened or if he felt unsafe, to seek emergent medical attention. Pt verbalized understanding and intent to seek treatment should symptoms worsen.
SWELLING ON HER RIGHT UPPER LATERAL THIGH ABOUT 2 CM, ALSO DEVELOPED A FEVER UP TO 101.5 RESOLVED WITH TYLENOL SWOLLEN, PAINFUL, LIMPING WHEN WALKING.
He did feel good. On Oct. 3rd he came down with cough with mucus, headache, chills,no fever.  Stomach and urinary tract hurt.  On Oct. 5 or 6 he had an increased hearing problem.  On the 6 or 7th he ran a temp of 102.
severe vomiting starting @ 1030PM on 8FEB97 lasted 24hr;mom contacted family MD;
after it was out past room temperature past the 12 hour mark and it was actually at 73 to 76 degrees for approximately 31 hours/There was HPV vaccine given to him also on 04Apr2023; This spontaneous report was received from Registered Nurse via Pfizer, referring to a 20-year-old male patient. The patient's historical vaccines included first and second doses of Pfizer covid vaccine. Information regarding the patient's concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided.  On 04-APR-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered in the right arm as prophylaxis (dose, route of administration, and vaccination scheme frequency were not reported; lot number W011455 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe, expiration date reported and upon internal validation established as 11-DEC-2024); and tozinameran (PFIZER BIONTECH COVID-19 VACCINE) (reported as Pfizer Bivalent covid vaccine for adults 12 and up), at a dose of 0.3ml given intramuscular to the left arm, as prophylaxis requested for the patient (strength and formulation were not reported; lot number reported as GL1990 and expiration date were not reported). According to the reporter, they had a vaccine administered after it was out past room temperature past the 12 hour mark and it was actually at 73 to 76 degrees for approximately 31 hours and she wanted to confirm the integrity to inquire if the patient needed to be vaccinated (it was unclear if hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion) (product storage error).
deathly sick; extreme vomiting; diarrhea; stomach pain; severe indigestion; nausea; pain in his arm; very tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2), administration date 23Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "prostate cancer" (ongoing), notes: Wife, calling behalf of husband, aged 58 who is currently undergoing active treatment for advanced prostate cancer. Concomitant medication(s) included: FIRMAGON; ZYTIGA; PREDNISONE. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "pain in his arm"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "very tired"; ILLNESS (non-serious) with onset 25Feb2021, outcome "unknown", described as "deathly sick"; VOMITING (non-serious) with onset 25Feb2021, outcome "unknown", described as "extreme vomiting"; DIARRHOEA (non-serious) with onset 25Feb2021, outcome "unknown", described as "diarrhea"; ABDOMINAL PAIN UPPER (non-serious) with onset 25Feb2021, outcome "unknown", described as "stomach pain"; DYSPEPSIA (non-serious) with onset 2021, outcome "unknown", described as "severe indigestion"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea".  Additional information: The patient (Age:58, Unit: Unknown) is due tomorrow to receive the second dose, but was not going to get it. He got very very sick. The day before the vaccine the patient had his monthly injection of Firmagon, an ADT drug,  Daily, he takes Zytiga 4 pills and Prednisone 5mg daily. Initially after the vaccine, the patient had pain in his arm and was very tired. Then two days later, on Thursday he started pelvic radiation he was deathly sick. The patient experienced extreme vomiting 13 times, diarrhea and stomach pain. Then Friday, he went for radiation again and had the same symptoms. Radiologist said it was not from the radiation. Oncologist it could be the medications interacting with the vaccine. He goes daily five days a week and doesn't want to get the second dose. Over the weekend, he was a little sick but did not have radiation those days.  He had severe indigestion. The following Monday and Tuesday he had some nausea. Wednesday the radiation machine was broken so he did not receive it that day. Then on Thursday he tolerated it okay.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling, induration and redness (2 thigh) 4.0x4.5. Rx with cold compress, Benadryl, Duricef.
Very warm to touch, pale, dizziness, tingling of finger, non responsive for 15-20 sec.
fever fatigue muscle aches headache onset midnight  Double vision 3pm 5/20/22
child with vomiting and diarrhea from 5/22/2007.  Seen 5/23/2007 with negative rotovirus.  Seen 6/05/2007 an positive rotovirus
Moderna COVID-19 Vaccine EUA          I woke up sat.  01/30  with severe Vertigo.  This lasted till early mon. morning.   The dizziness left but I was so weak, I was in bed for one more day.  By tues. I felt better, but it took till thurs. to feel normal again.    I'm   wondering if this was a reaction since it took three days to  start.     I did notify my dr.  Dr. to see if he thought it might be covid rather than a reaction, but he opted to wait 24 hours & check back with me for a Covid test.  Since I was feeling better every day, we let it go.   My question is  should I receive the second shot?
On 01/06/2022 at approximately 09:15 administered Moderna booster. Patient complained of right hand and right forearm itching shortly after. O2 SAT 98%, HR 119 and redness to right hand forearm after he scratched. No rash or redness to chest, abdominal area or left arm. He denied shortness of breath or trouble with swallowing. No signs of distress. Called 911. At 09:28 accompanied him to the triage/treatment area. He ambulated with a steady gait. No signs of distress. At 09:42: HR 106, RR 16-20, BP 138/81 and O2 SAT 100%. No signs of distress. He laughed while speaking to staff present after it was discovered he had a quarter sized irregular shaped "love bite" to anterior right deltoid. No redness to right hand or right forearm area. At approximately 09:50, he declined to be cared for by paramedics.
Left arm very sore - started a couple of days after second vaccine was given on 5/22/2021. Area where vaccine was given is hard, red, rashy, painful, and warm. Now bruised but that could be from my scratching. All symptoms are tolerable right now and do not need medical treatment. After reading an article on "Covid arm" I decided to report this in the interest of science and providing data to advance understanding.
Nausea, H/A, took 2 Tylenol. At 10pm started feel ill, achy, Had trouble breathing over night. The albuterol didn't help. Heart beat was fast. 1/13/20 in the am had a H/A, took 2 Tylenol.  The breathing got better around noon.
Patient for first COVID-19 shot per order of doctor with 60 minutes observation time.   Moderna vaccine 0.5 ml given IM left deltoid at 0918 AM.   Moderna COVID-19  Lot: 048F21A Exp: 10/8/2021  At 0928 AM, patient reports tightness in the chest and tingling at the tip of her tongue.  Red patches appeared on the neck and upper chest area.   Per order of doctor, Epipen 0.30 mg injected right thigh 0933 AM and benadryl 50 mg/1ml IM injection at 0940 AM. Patient kept in clinic and observed for 2 hours with normal vitals. Patient discharged home at 1140 AM
she has had a full blown psychosis episode; This is a spontaneous report from a contactable consumer. This contactable consumer (Patient's mother) reported for 34-year-old female patient.  A 34-year-old female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 04Sep2021 (at the age of 34-year-old) as dose 2, single for COVID-19 immunization. Patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in right arm on 12Aug2021 (at the age of 34-year-old) as dose 1, single for COVID-19 immunization and experienced the patient was a little bit off/different but she didn't think much of it since she had not had a psychosis episode in a long time. Patient also received pneumonia vaccine on 13Aug2021 at the age of 34 years. The patient medical history includes Psychotic disorder, Allergy, pneumonia vaccine, Penicillin allergy, Shellfish allergy, Latex allergy, Pollen allergy, and Bladder disorder, Environmental allergy, and concomitant medications were not reported. Past drug event includes MAGNESIUM induced unknown reaction, SUMATRIPTAN induced unknown reaction and IODINE induced unknown reaction. On 04Sep2021, after the vaccination, the patient experienced a full-blown psychosis episode. The psychosis started the night of 04Sep2021, and it was full blown psychosis by the next morning 05Sep2021. Caller reports that she couldn't get the patient to take any of her meds and she was going to take her to the Emergency Department. The outcome of the events was not recovered.  No follow-up attempts possible. No further information expected.