chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diarrhea with "some" blood in the stool; the patient was "spitting" up a lot.; vomiting the entire day; the patient is still "fussy"; This spontaneous report was received from a doctor concerning a 4-month-old female patient. Pertinent medical history included prolonged jaundice, persistent direct hyperbilirubinemia and hemangioma. Concomitant therapies included diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 13V (CRM197) (reported as PCV 13).     On 11-AUG-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (1 DS X 10 TUBES 00006404741; lot # 1707460 has been verified to be valid, expiration date reported as 14-MAR-2022; strength was unknown), 1 time dose, orally for prevention of rotavirus gastroenteritis.      On 11-AUG-2021, about an hour after the patient had some food, she experienced vomiting the entire day. The next day the patient was spitting up a lot. On 14-AUG-2021, the patient had diarrhea with some blood in the stool, and streaks of blood in the stool that continued for 2 days. The patient came in to see the doctor on 16-AUG-2021 (also reported as yesterday), and on exam it was noted no abdomen distention and no signs of intussusception. The doctor confirmed that the patient was still "fussy" (onset date: on unknown date in August 2021). The treatment was not given for the events. The patient was recovering from the events. The doctor was reporting this adverse event for rotavirus vaccine, live, oral, pentavalent (ROTATEQ). The reporter considered all events to be related to Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ).  Upon internal review, blood in the stool was determined to be medically significant.
Dizzy, unable to walk straight, needed assistance to restroom. Lasted 2 days
This is a spontaneous report received from a contactable pharmacist. A 41-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown),  2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed illness/was ill, with outcome of unknown. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
fever of 104 started 7AUG93 lasted 24 hrs vomiting 4 hrs; fever of 102 on 8AUG93 lasted 12 hrs; measles type bumps (red) appeared on face, torso, & buttocks on 6AUG93 lasted 6 days; treated sx w/Tempra drops
Site: Pain at Injection Site-Mild, Systemic: pain in leg-Medium, Systemic: Joint Pain-Medium, Additional Details: Patient daughter called a few hours after getting vaccine and stated that he was experiencing severe leg pain. NO issues in the arm but the leg pain started right after vaccine he stated
NO ADRs- reporting to database since patient received 2 series (4 doses) of Shingrix
Had been feverish & drowzy since immun; given APAP & @ 520PM began to jerk, gag & gasp for air was taken to ER w/t104;
Patient rec'd Tdap 3-16-16 on 3-18-16 presents to the clinic with a small red, warm lump at the injection site.
Presented to ER on 12/18/21. received moderna vaccine on 02/25/21, 03/24/21, and 12/6/21. COVID positive on 12/13/21. He was short of breath and was admitted on  12/13/2021. Since his admission, he has significantly improved in terms of his clinical  situation.  He stated that his breathing is so much improved. He has been diagnosed also with a small focus of acute pulmonary embolism  involving the right middle lobe.  No evidence of obvious right heart strain. The patient has received remdesivir (5 day duration) since admission.  Also, currently, on antibiotics with Rocephin and doxycycline. He is also on Decadron 6 mg IV daily as part of the Covid treatment protocol. Passed away on 1/13/22
Chills that could be described as almost violent, temp. of 103.00, dizzy, terrible headache  all starting around 11:30pm on the same day as injection.  The next morning continued headache that hurt my eyes, temp. of 100.5, dizzy
1) whole body aches and pains - started 5 am next day (approx 15 hrs post injection) and gone by 6 am 2nd day 2) dizziness - started 5 am next day, lasted for 2-3 hours 3) redness and swelling at injection site - started 5 am next day, an increase was noticed again 5 am 2nd day, continues to be monitored
immunocompromised patient got booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient got booster dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient got booster dose). At the time of the report, ACCIDENTAL UNDERDOSE (immunocompromised patient got booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   An immunocompromised patient, received a booster dose of 0.25 mL instead of a third full dose of 0.5 mL
Within 2 hours, injection site started swelling, looking red and became painful. Chest began to hurt and patient took nitrates. Diarrhea started, which she says was the worst she has ever experienced. Other symptoms have improved but is still experiencing some diarrhea.
I have not had a menstrual cycle since receiving the covid-19 shot. I am not pregnant. I have been checked 3+ times by my general doctor for pregnancy.
Headache, Myalgia & Arthralgia Narrative: Mild symptom onset, presented to clinic to report. No further actions.
This spontaneous report as received from a healthcare worker refers to a 53 year old female patient. The patient's current conditions or medical history were not reported. On 18-FEB-2014, the patient was vaccinated with ZOSTAVAX vial dry SD 0.65 ml subcutaneously (lot J011882, exp date 04-JAN-2014). Concomitant medications included lisinopril (manufacturer unknown) and KLONOPIN. On 19-FEB-2014, the patient developed a few bumps around injection site that looked like shingles rash. The patient had had several cases of shingles and she identified those bumps as shingles-like rash. The patient did not reported any pain. At the time of the report the patient was not recovered from bumps around injection site that looked like shingles rash. The patient called the office to sough for medical attention and did not received treatment for the events. No lab diagnostics were performed. Additional information has been requested.
Unsure of exact immunizations (they were given at Clinic) c/o right shoulder tingling pain at time of injection, soreness x few days, but now with decreased range of motion and pain right shoulder after receiving Tdap and typhoid immunization in right arm.
a temperature excursion, requesting stability data; This spontaneous report as received from a registered nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, drug reactions/allergies and concomitant therapies was not provided.    On 21-OCT-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (1 dose, lot # S038700, expiration date 01-DEC-2021; strength and route of administration were not reported) for prophylaxis (product storage error). Current temperature excursion was -6.6 Celsius degrees for 1 hour and 45 minutes. There was no previous temperature excursion. No product quality complaint (PQC) was reported. Data logger was involved.
3 weeks later, panic attack episodes, eyes sensitve to light, light headed/dizzy, shortness of breath, eye flutters, inflammation in the eye, Intermediate uveitis
very itchy red rash at inj site, fever at site, took benadryl and tylenol for symptoms did help, however rash has came back8 days later same thing.
Mother stated that after the immunization baby was limp for 1 -1 1/2 days and not moving, extremities with frog leg position, cried alot and did not sleep. Went away the following day. Incident and vaccinations occurred on 4/24/06 but the report was completed on 8/10/06. On 8/10/06 infant received DT and had no problems, per discussion with clinic.
Vision loss in Left eye in addition to the normal side effects listed; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 20Apr2021 09:45 (Lot Number: EW0170) at the age of 30-year-old at a single dose for covid-19 immunisation in hospital. The patient's medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccine. The patient previously took amoxicillin and codeine. The patient experienced vision loss in left eye in addition to the normal side effects listed on 20Apr2021 13:00 which result in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the adverse event. Prior to the vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.
Fever; chills; muscle ache; Fatigue; Difficulty communicating; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 03May2021 at 16:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any concomitant medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER9729) via an unspecified route of administration in the left arm on 05Apr2021 at 09:30 (at the age of 47-years-old) as single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 04May2021 at 10:00, the patient experienced fever (101.3 from 10 am to 4 pm, 101.0 from 4 pm to 8 pm), chills, muscle ache, fatigue and difficulty communicating. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen, 500mg, oral, two doses. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, or emergency room/department or urgent care. The clinical outcome of the events fever (101.3 from 10 am to 4 pm, 101.0 from 4 pm to 8 pm), chills, muscle ache, fatigue and difficulty communicating were recovered on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: added medical history as none, event difficulty communicating updated as communication disorder.
BLOOD CLOT; UNABLE TO WALK; This spontaneous report received from a patient concerned a male of unspecified age with unknown race and ethnicity.. 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, batch number: Unknown, expiry: unknown) dose was not reported, 1 total, administered on 13-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  In JUL-2021, the patient had a blood clot and 2 weeks later patient could not walk.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot and unable to walk was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210806835- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Blood clot. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Redness, discomfort, warm feeling in area of injection approximately 2 inches wide.
Patient got a 3rd dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number C9Z43, expiry date 08-JUL-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 14-APR-2023, the patient received the 3rd dose of Shingrix. On 14-APR-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Patient got a 3rd dose of Shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 19-APR-2023 The second dose of Shingrix received on 28th February 2023. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The reporter called to inform that a patient was administered a 3rd dose of Shingrix, which led to extra dose administered.
get the Covid Virus at Christmas time/Tested Positive for Covid after receiving 3 Doses of the Covid Vaccine; get the Covid Virus at holiday time/Tested Positive for Covid after receiving 3 Doses of the Covid Vaccine; had just a mild cold; he went hiking his normal hike loop trip in the local mountains and after 1.5 hours he ran out of gas and became breathless; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EN6208) at the age of 74 years, on 05Apr2021 as dose 2, single (Lot number: ER8737) and on 26Oct2021 as dose 3 (booster), single (Lot number: FG3527) for covid-19 immunisation. The patient's relevant medical history included: "SIBO" (unspecified if ongoing), notes: SIBO, Small Intestinal Bacteria Overload.; "High Blood Urea Nitrogen" (unspecified if ongoing); "Type 1 diabetes mellitus", start date: 1982 (ongoing). Concomitant medication(s) included: LEVEMIR taken for blood glucose decreased; NOVOLOG taken for diabetes mellitus; HUMALOG taken for diabetes mellitus.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "get the Covid Virus at holiday time/Tested Positive for Covid after receiving 3 Doses of the Covid Vaccine"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "had just a mild cold"; DYSPNOEA (non-serious), outcome "unknown", described as "he went hiking his normal hike loop trip in the local mountains and after 1.5 hours he ran out of gas and became breathless". The events "had just a mild cold" and "he went hiking his normal hike loop trip in the local mountains and after 1.5 hours he ran out of gas and became breathless" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood urea: High; Electrocardiogram: 44 bpm; SARS-CoV-2 test: Positive.  Clinical information: Caller stated he did get the Covid Virus at holiday time. Caller stated everyone there was getting it. Caller stated he thought he had just a mild cold so he said that was fine, he hadn't had a cold since 2016 so he went hiking his normal hike loop trip in the local mountains and after 1.5 hours he ran out of gas and became breathless. Caller stated he continued but it was not a pleasant experience, but going downhill was fine because he was in good condition. Caller stated he talked to his doctor and found out he had Covid and he was going to have side effects for 3 months.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200811906 Same patient, different event/dose
I have fever from Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of fever 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 fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient have fever from Shingrix. The patient asked what was normal range.
Information has been received from a physician concerning a 13 month old male who on 11-JUN-2007 was vaccinated subcutaneously with the "first dose" of PROQUAD (lot # 657555/0487U). Concomitant therapy included HAVRIX and PREVNAR. On 20-JUN-2007 the patient experienced nickel size hive by injection site. The patient sought unspecified medical attention. The outcome was not reported. There was no product quality complaint involved. Additional information has been requested.
heaviness in her chest and bones; heaviness in her chest and bones; hot flashes; has not slept in four days; her whole body swelled up; This is a spontaneous report from a non-contactable consumer or other non hcp via medical information team. This consumer reported similar event for 2 patient (Herself and her Brother-in-law). This is second of 2 report (Brother-in-law). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced heaviness in chest and bones, hot flashes, had not slept in four days and whole body swelled up. The outcome of the events were unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021263737 same reporter/drug/AE, different patients
Transplant patient received vaccine on 10/10/17 & developed all over body rash that resembled "mosquito bites" and was very itchy. Pt stated rash lasted approximately 2 weeks. Used "Aveeno" to help with itching.
Diarrhea; Nausea; This is a spontaneous report from a contactable Other health care professional (HCP) (patient). A 20-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Dec2020 at 06:00 PM at single dose in Right arm for COVID-19 immunization, Lot number: EK9231. Medical history included covid. No known allergy to medications, food or other products. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and trazodone. On 23Dec2020 patient experienced diarrhea and nausea. Patient received anti diarrheal as treatment. Since the vaccination patient had not been tested for COVID-19. Patient was recovering from the events.
Initial misuse report received from a healthcare professional on 08 November 2013. On unspecified date a 16-months-old patient had received a dose of FLUZONE ID. Intradermal vaccines have not been administered in persons less than 18 or 65 and over years of age. It's an inappropriate age at vaccine administration. No adverse event was reported. List of documents held by sender: none.
while in post vaccination observation, client thrust head back into the wall, while in a seated position.  Became unconscious.  Left arm tremor- observed.  diaphoretic, skin warm to the touch, sweating.  When client became alert and oriented, he was fearful of the situation and began to cry.  stating he didn't know what happened, he was scared,  and he was dizzy and didn't feel well.  Patient given emesis bag, given water and Ice pack.  He also reports no ability to alert anyone prior he had no physiological indicators of what was about to happen.  He urinated himself.  He then had the second emesis and EMS alerted and on site to assess patient .
Within 2-3 days of vaccination the soreness at the administration site in my right arm was gone, but I began to feel pain in my right elbow when lifting objects.  Also, within 3 weeks I developed a prostate infection (I don't know if this is related to the vaccination, but it also a strange coincidence, if it is not).  The manufacturer of the influenza vaccination is Adventis, Lot #UO938AA.
I tested positive for Covid-19. I started developing symptoms on 12/30/2021. My symptoms included sore throat, achiness, body weakness, severe sinus headache, runny nose, and tiredness. I was taking Advil every 4 hours the first 3 days. I also took Sudafed.
Swollen lower lip 2nd day after vaccine; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9265) dose 1 via an unspecified route of administration on 02Feb2021 01:30 PM as single dose in left arm for COVID-19 immunization. Medical history included abdominal discomfort. No other vaccine in four weeks. Patient was not pregnant. No covid prior vaccination. Other medications in two weeks was reported as yes. Known allergies was reported as yes. The patient's concomitant medications were not reported. The patient experienced swollen lower lip 2nd day after vaccine on 03Feb2021 09:00 AM. No treatment for adverse event. No covid tested post vaccination. The outcome of event was recovered in 2021  Follow-up attempts are completed. No further information is expected.