chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had abdominal pain and diarrhea and treated that with OTC. I had a routine colonoscopy the following Friday and they found acute and chronic Colitis. The second health event that started 12/19 I had an upper respiratory cold with drainage and cough. On the 23rd I went to urgent care and tested positive for Flu type A. I was given symptomatic medication and it's mostly better now.
MA MISTAKENLY GAVE THIS PATIENT THE BEXSERO VACCINE WHEN HE WAS ACTUALLY DUE FOR MENACTRA.  MESSAGE LEFT WITH MOTHER TO INFORM OF VACCINE ERROR AND I HAVE NOT BEEN ABLE TO REACH HER.  SPOKE WITH OUR LOCAL IMMUNIZATION MANAGER AT THE HEALTH DEPARTMENT AND SHE STATES THAT THE CHILD SHOUL D NOT RECEIVE THE 2ND DOSE AT THIS TIME. HE WILL NEED TO RESTART SERIES AT AGE 16.  HE STILL NEEDS TO COME IN AND GET MENACTRA. WILL CONTINUE TO TRY AND REACH PARENT.
Sore arm at injection site that moved into armpit, fever, chills, body aches, restlessness and insomnia
softball sized rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2020, the patient received Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional information was provided as follows: The reporter was a patient's wife. The age at vaccination was not reported. The patient received shot last saturday from the time of reporting and experienced softball sized rash. The reporter wanted to know was this normal. The reporter consented to follow up.
Developed vaccine-related varicella zoster (R) arm C-8 dermatome.
Within a day developed chest pain, tightness, heaviness, palpitations. Progressed over time. Repeated ER visits. Later diagnosed with Postural Orthostatic Tachycardia Syndrome. Am now completely bedridden.
after the initial pain of the shot wore off, her left arm increased in pain radiating into her forearm over the next few weeks.
2nd dose was received one week early - individual is a foreign exchange student that did not have her vaccination card present with her
This spontaneous report as received from a nurse refers to a 6 months 13 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Real sick when they got their second dose of the Covid-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Vertigo" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st shot of covid vaccine), for Covid-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Real sick when they got their second dose of the Covid-19 vaccine".  Additional information: The patient had no prior vaccinations within 4 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1.)hard mass an in inch below the injection =  grew from the size of a nickel to the size of a Ping-Pong ball associated with pain; lasted 7 days.  2.)  pink rash below the mass, with itching, lasted 7 days.  3.)  swelling and  pain level 2-5, lasted 8 days.  . 4.) Headache and chills, just overnight.
Severe headache, irregular heartbeat, tiredness and fatigue since first shot and getting worse after second shot
Large red spot. Warm to touch. Was about 2.5 inches across when first noticed. 4 days later still warm , however now 5.5 inches across.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. There was no information about patients' pertinent medical histories, concomitant medications, drug reactions or allergies reported. On an unknown dates, the patients were vaccinated with improperly stored PROQUAD (Merck) injection (lot# K009470, expiration date 03-JAN-2016, dose, anatomical location and route administration were not reported). Additional information has been requested.
Rash started on left shoulder at injection site then rash spread down the left side of chest and back red raised and itchy patient was given script for predisone, triamcinolone and suggested to take benadryl and Zyrtec.
At about noon on 01/28/21, I started to experience some fatigue.  At about 9:30-10:00 PM, I started to experience fever, chills, and I was very weak and fatigued. This lasted for about 3 days. I took 800 mg ibuprofen every 6 hours to manage the fever and chills. The left arm was very sore from the shot. The symptoms reminded me of what I had experienced when I had COVID in 4/2020, so I went to the doctor on 1/29/2021. I went urgent care at about 10 AM. The doctor told me to not be alarmed, because the symptoms were normal effects of the vaccine. He advised me to keep taking the ibuprofen and to possibly also take Tylenol and to monitor the symptoms.  On the third day, I woke up feeling better. I didn't have chills or fever anymore. This was on 1/31/2021.
woke in the middle of the night with body aches, fever, chills- which was expected but also chest pain- it persisted so did a video visit and they sent me to Urgent care- there did work up but cont with tacycardia and pain so admitted for further work up- took ambulance transport to hospital; spent the night on telemetry and got ECHO- LFT's are elevated and D dimer elevated;  after home still with occasional chest pain - follow up needed with PCP
Nurse saw 10mcg and not the 0.2ml, pt received the Moderna 6yr-11y vaccine the volume in the syringe was equal to 0.1ml per the nurse.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 27-OCT-2014, the patient was vaccinated with a dose of PROQUAD lot # K009894, expiry date: 11-JAN-2016 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
on the lower part of the arm pit,there was like a swollen ball.; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (on the lower part of the arm pit,there was like a swollen ball.) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (on the lower part of the arm pit,there was like a swollen ball.). At the time of the report, LYMPHADENOPATHY (on the lower part of the arm pit,there was like a swollen ball.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided  No treatment medication was provided
Information has been received from a physician concerning a patient who was vaccinated PO with a 2.0 mL dose of Rotateq (human bovine). The physician reported that the patient developed diarrhea symptoms while being administered Rotateq (human bovine). Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional informatio has been requested.
Last night (090904), Mother noticed rash on child's chest.  This AM child had itchy red rash and hives all over her body.  Hives varied in size from pinpoint to eraser size with heaviest coverage on trunk.  Hives also located around mouth and on lips, ears, head and extremities.  No fever was present.  Child was taken to a dermatologist this AM.  Doctor told the parent that it was probably a strep infection but he could not rule out the possiblity of a vaccine reaction.  No lab tests or cultures were done.  Child was prescribed Zithromax.
Information has been received from an RN concerning a 6 day old male relative who on 11/6/01 was vaccinated with Hep-B vaccine recombinant (yeast). On 11/10/01, the child died. The cause of death was unknown. Autopsy report states child's age at time of death to be 18 days old. Cause of death is traumatic compression of head and chest due to overlaying, manner of death accidental.
Patient stated she went home after the vaccine and took a nap. When she woke up her arm was very sore and difficult to move. She wanted to make sure this was reported.
Shingles rash outbreak on left side of body with accompanying chest and back pain and fatigue- still ongoing.
Patient/employee telephoned on 11/14/07 to report onset of symptoms on 11/03/07 of "golf ball size" redness.  T99.6 orally.  On 11/04/07 also swelling with the redness and soreness/muscle discomfort.  By 11/14/07 decreased symptom: redness now fading "black and blue" greenish.
5/15/11 - onset of rash, small red papules on neck. 5/17/11 - rash developed into much larger coalescing raised red macules and plaques on face, arms, legs, spares trunk, back. No fever, no itchy. Pt acting well & normal.
This case was reported by a nurse via sales rep and described the occurrence of pain in extremity in a 63-year-old female patient who received SHINGRIX for prophylaxis.  On 27th November 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in extremity, headache, nausea and impaired work ability. On an unknown date, the outcome of the pain in extremity, headache, nausea and impaired work ability were unknown. It was unknown if the reporter considered the pain in extremity, headache, nausea and impaired work ability to be related to SHINGRIX. Additional details were provided as follows: The patient experienced pain in her arm and leg as well as a headache and nausea. She had to stay at home from work one day.
Chills, cold sweats, body aches, fever 99°-101°, very sleepy for Approx 40 hours
Outgoing call to patient's mother to discuss incorrect dose amount of Moderna 23/24 6m-11 given on 10/24/2023. Patient's ordered dose was 0.25mL but was given approximately between 0.4-0.5mL. Patient's mother expressed understanding. Instructions provided to monitor patient for additional or prolonged side effects with call back number for Nursing Supervisor. Additionally, a message sent to patient's PCP informing them of error. Father called to request a letter containing information about the administered dose in order to contact the CDC and ascertain whether any additional precautions are necessary.
Red  area around injection site. Oval about 4x3 inches Sore and warm to touch
rash; This case was reported by a other health professional via interactive digital media and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. The patient was treated with steroids nos (Oral Steroids). On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingles vaccine and experienced rash. The patient was treated with oral steroids and responded well but 5 days after rash came back. The reporter asked for recommendations. The follow-up would not possible, as no contact, details were available.
YF-VAX was administered using an expired diluent with no reported adverse event; Initial information received on 25-Oct-2021 regarding an unsolicited valid non-serious case received from a other health professional and non health care professional via Medical Information number: 00826516.  This case involves 58 years old female patient was administered expired YELLOW FEVER VACCINE - US [YF-VAX] (expired product administered).  This case is linked to cases US-SA-2021SA356051, 2021SA357534 and 2021SA356051(CLUSTER).  The patient's medical history, past medical treatments, vaccinations, and family history were not provided.  Concomitant medications included TYPHOID VACCINE (TYPHIM).  On an unknown date, the patient received a 0.5 ml dose of suspect YELLOW FEVER VACCINE - US (lot number: U6428AA and expiry date: 30-SEP-2021) via intramuscular route in the left deltoid site for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.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.; Sender's Comments:  US-SA-2021SA354616: US-SA-2021SA356701: US-SA-2021SA354618:
coughing; viscous cold/ got the same cold again. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old male patient received bnt162b2 (COMIRNATY), administration date 11Sep2021 (Batch/Lot number: unknown) at the age of 80 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 11Aug2021, when the patient was 80 years old, for COVID-19 immunization. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 11Sep2021, outcome "not recovered", described as "viscous cold/ got the same cold again."; COUGH (non-serious), outcome "unknown", described as "coughing". The event "viscous cold/ got the same cold again." was evaluated at the physician office visit. Therapeutic measures were taken as a result of nasopharyngitis.  Additional information: It was reported that, he has had two colds, one lasted 2 months, after being vaccinated with Pfizer's Covid19 vaccine. One started last week and he had to have it treated by his doctor. It might be leaving the body in cold. He is getting very viscous colds that he had never had before. He got vaccinated on 11Aug2021 and got second shot three or four weeks later on 11Sep2021. Then he had a cold from 11Sep2021 to 07Dec2021. Then it lifted off. He had to be treated with antibiotics and typical cold remedies. Then it vanished and he felt really great. Then at the first of the year he took a local trip and came back and got the same cold again. When he says same cold he didn't check, but it was viscous and he was coughing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Employee has received flu shot yearly with not adverse effects. This year developed swelling over eyes and forehead and itching in her throat that lasted several hours. Also stated she felt like she does when she has a sinus infection. Reaction started within a few minutes of receiving vaccine and she was sent to emergency department for follow up. No hives, no difficulty breathing or swallowing. She was given Benadryl and Solu-Medrol IV.
lightheaded, nauseous, dizziness, rush of heat, throat swelling, congestion
On January 14, 2022 patient  came home from school with symptom of shortness of breath only. She was seen at an urgent care that day and tested negative for COVID. The physician there was concerned for refiux so she was given a medicine to treat this. She developed fever on 1/15 up to 105. That same day she was seen by the PCP as she also developed chill, body aches and had continued SOB. She was admitted to hospital.  During the course of her admission, she was found to have elevated inflammatory markers. Given the concern for her new murmur, an echo was obtained. It demonstrated a large, circumferential pericardial effusion with concern for possible tamponade physiology. Cardiology, rheumatology, and infectious disease were brought on board. While there was some initial concern for MIS-C, the clinical history, only mildly elevated inflammatory markers, and single organ involvement did not fit MIS-C and the decision was made to begin treating patient for pericarditis.
It called erythema nodosum and it's an allergic reaction under your skin mostly in the lower leg. Red lumps and inch in diameter. They did varied tests and couldn't determine specific cause. It went away in about 6 weeks.
I got lightheaded and I took my blood pressure at home with the machine I have, and it indicated that I have an irregular heart rate. I saw my cardiologist who put a heart monitor on me for two weeks to monitor my heart to see what is going on. I had an electrocardiogram, and the results were normal. I do not have any results from the heart monitor at this time because I have to wear it for another week.
Small rash on abdomen day of and resolved in a few days. Bruising at injection site started the evening of vaccination and progressively spread down the same arm to antecubital, small bruises on arms, and large one on left leg.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 71-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). On 4th February 2018, the patient received SHINGRIX .5 ml. In February 2018, less than a week after receiving SHINGRIX, the patient experienced injection site warmth. On an unknown date, the outcome of the injection site warmth was not recovered/not resolved. The reporter considered the injection site warmth to be probably related to SHINGRIX. Additional details were provided as follows: The case was reported by a Registered pharmacist. The patient received SHINGRIX in left deltoid. The reporter saw patient today (at the time of reporting) and the patient reported having warmth in the arm where she received the injection. The reporter referred her to urgent care but the patient said she was just going to call her physician. She did not have access to urgent care.
Faint, dizziness, disorientated, pale, clammy/sweating, sensation that the room was spinning, unable to walk, nauseated, excruciating migraine headache pain, light & sound sensitivity.
This spontaneous report was received from a consumer as part of a Market Research Program refers to one of her daughter's friend a 13 year old female patient. The patient's medical history included lead poisoning as a child. On an unknown date in 2000, the patient was vaccinated with GARDASIL (route and lot# were not reported) dose 1. On an unknown date in 2000, the patient experienced pain lasting a week and the patient was in bed for a week after GARDASIL injection. None of her other friends choose to take GARDASIL because of stated events. Action taken was reported as interrupted as the patient did not receive the second dose. On an unknown date in 2000, the patient recovered. The reporter considered pain to be related to GARDASIL. The reporter considered the seriousness of the event pain lasting a week and the patient in bed for a week to be disability. This is one of the two reports from the same reporter. Additional information has been requested.
Tinnitus so loud it wakes me up when I am sleeping. The tinnitus is heard whenever I am awake.  It is miserable and makes it very hard to concentrate.
Right arm is red & hot from elbow to shoulder; patient went to a local hospital for treatment.
This spontaneous report as received from a Licensed Practical Nurse (L.P.N.) refers to unknown number of patients of unknown gender, age and medical history. Approximately in 2013, the patients were vaccinated with PNEUMOVAX23 (lot# not reported) (dose, strength, route not reported) which had been exposed to temperature as low as 32 F on occasions in November 2013. No adverse effect was reported. Additional information has been requested.
Body itching; This case was reported by a consumer via interactive digital media and described the occurrence of generalized pruritus in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced generalized pruritus. On an unknown date, the outcome of the generalized pruritus was unknown.   It was unknown if the reporter considered the generalized pruritus to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was not reported The age group was not reported but captured as per vaccine indication The patient received Shingrix and experienced body itching. No other information was available
Pt returned to pharmacy area complaining of dizziness and shortness of breath (SOB). A lump had developed at injection site. I had her sit down and a technician kept her under observation. She never got any worse and improved enough to walk around for 5 minutes to be sure she was ok. Unable to follow up as pt provided disconnected phone number.
extreme migraine; This spontaneous report was received from a medical assistant via company representative referred to a 17-year-old male patient.  The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection for Human Papilloma Virus (HPV) infection prevention (prophylaxis) (dose, route, lot # and expiry date were not reported). The patient was also concurrently vaccinated with meningococcal b rfhbp vaccine (e. coli) (TRUMENBA) for prophylaxis (dose, route, lot # and expiry date were not reported). On an unknown date, after the administration of suspect products, the patient's mother contacted the facility to inform that, the patient was experiencing extreme migraines (sought medical attention). The outcome of the event was not reported. The reporter did not provide any causality assessment. The product quality complaint was not involved.