chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a patient's mother regarding her son of 13 months. Patient's current condition included ear infections. On 27-MAR-2014 the patient was vaccinated with VARIVAX (Merck) injection (dose number, dose unit, lot# and expiry date, therapy route unknown). No concomitant medications were reported. On 31-MAR-2014, the patient was diagnosed with an ear infection and low grade fever. Patient was treated with an unspecified antibiotics at the time of the report. It was reported that patient was scheduled for a placement of tubes in the ears on 04-MAR-2014 but was cancelled until the ear infection would resolve. Outcome of the events was reported as not recovered. Causality of events with respect to VARIVAX (Merck) was unknown. Additional information is not expected.
now it is like 47 days (after first dose to get second dose); This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (now it is like 47 days (after first dose to get second dose)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (now it is like 47 days (after first dose to get second dose)). On 09-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (now it is like 47 days (after first dose to get second dose)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was around 22-23 years old. No relevant concomitant medications were reported.  No treatment information was provided.
13 hours after receiving Dtap shot I came down with severe chills, fever, vomiting, headache, and 1 diarrhea.  Fever got close to 103 and lasted most of the day as did the vomiting.  Fever broke after taking ibuprofen around 5:00 in the afternoon.  I feel better today after one day of being in the bed sick but I am very weak and sore.  I do not have health insurance so I rode it out.
My COVID-19 symptoms started on 01/24/2023 in the morning. I felt achy, nausea, nasal congestions.  I wasn't feeling good. I took 2 rapid tests one on 01/24/2023 and 01/25/2023 which were negative. I had elevated heart rate doing simple tasks then it resolved within few minutes.  I did a PCR test on 01/26/2023 which was positive. I called my doctor on 01/25/2023 and did a telehealth. He prescribe me Lagevrio 2 times a day for 5 days. The first time I had Atrial Fibrillation was on  01/19/2023 I was at the ER   for few hours and the second time I had Atrial Fibrillation  was on  02/23/2023. I was admitted at the hospital for 2 days and I was discharged the next day. My heart was racing. I had difficulty breathing and tightness in my chest. They changed my medication to Diltiazem. They did tests that showed possibility of blood clot. They transferred me over to the hospital to get other testes done. As of today I have recovered from Atrial Fibrillation and COVID-19 symptoms.
Patient received 2nd dose of Pfizer vaccine on 3.21.2021. 4 minutes after receiving the vaccine (1200), the patient came to the nurses station stating, "I feel like I'm going to pass out." Patient seated and given cool rag. Patient proceeded to feel difficulty breathing and itchy throat. Patient given 1 dose of epipen at 1205. Patient tolerated well. Patient states she is breathing easier at 1208. 1211, Patient drinking water, feels better. Pain 0/10. EMS called and transported to ER. Patient diagnosed with "vasovagal reaction" in ER. Physician noted that the patient has a history of panic attacks and that this incident felt similar to the patient. Patient has no difficulty swallowing, no ShOB, and/or swelling. Patient fully recovered from the reaction by the time she arrived to the emergency department. Patient discharged home with no restrictions.
Bitter taste in mouth; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 02Apr2021 at 16:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN) and ascorbic acid; colecalciferol; zinc citrate; copper citrate; betacarotene; sodium; calcium; sodium selenite; zingiber officinale rhizome; andrographis paniculata; vitis vinifera seed; marrubium vulgare; propolis; bioflavonoids nos; allium sativum bulb; olea europaea leaf; echinacea purpurea root,;zinc ascorbate; pueraria lobata root; inula helenium root; polygonatum odoratum rhizome; hydrastis canadensis root; sambucus nigra fruit; astragalus mongholicus root; tabebuia impetiginosa bark; cinnamomum spp; bark,;angelica spp. root; isatis spp; eleutherococcus spp (HERBAL WELLNESS FORMULA). 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 vaccination. On 02Apr2021 at 16:45, the patient experienced bitter taste in mouth about 10 minutes after receiving vaccine. It was reported that still present 14 hours later. The patient did not receive any treatment for the adverse event. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event bitter taste in mouth was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
The person giving vaccine injected into posterior head of humerus into joint or lagament.... exquisitely painful with pain going down right arm and into right hand, right palm right thumb
Fever of above 104 degrees Full body shaking/trembling Lips turned blue ---Reaction began with body aches and progressed to a fever that started from 101 and quickly climbed and held at above 104. Patient was unable to swallow fever reducers due to fever and body trembling. Physician ordered Tylenol suppositories and Benadryl 50mg for suspected allergic reaction. Suppositories brought fever down to 103 and stopped trembling so patient was able to take Benadryl 50mg orally. Fever continued but was controlled with Tylenol.
Immediate flushing, feverish (hot/cold and clammy), lightheaded, dizzy, elevated heart rate. 1-2 days after vaccination, started getting chest pains and heart palpitations. Heart issues starting to subside a week amateur, but still present.
Pt recv vax on 11/16/98; on 11/18/98 pt exp fever & seizure x1.5 min
This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 04-FEB-2015, the patient was vaccinated with MMR II (lot number: K002816 with unspecified expiration date) (dose, frequency and  route unspecified) that had underwent temperature excursion. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with MMR II, live was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
An MD reported the occurrence of jaundice in a 19 y.o. male who was vax'd w/Hep A vax inactivated for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were unknown. In approx Jan 02, the subject received his 2nd Havrix injection. In approx Oct. 02, the subject was seen by an MD for a cold, and the MD reportedly said, "You look a little yellow, you have Hep A." Subsequently, all tests (NOS) for Hep A were negative and his liver function tests (NOS) were "fine". The subject was still being tested to determine the cause of the jaundice. As of 10/31/02, the jaundice persisted. The outcome of the cold was not spec'd. The most recent info was received on 1/8/03. The reporting MD stated, "The case was a false alarm. It turned out not to be hepatitis. No significant disease." As of 1/8/03, the outcomes of the events were unknown. The jaundice in this report is considered GSK medically serious.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. On an unspecified day, the patients were vaccinated with improperly stored PROQUAD (Merck) lot # L002419 with the expiration date of 23-JUL-2016 (dose, unit and route were unspecified). No adverse effects reported. No product quality complaint involved. Additional information has been requested.
24 hrs after vaccine fatigue, 102 fever, malaise, 48 hrs after vaccine increased fever 103.4 so went to emergency dept of evaluation, 2 low blood pressure readings but of questionable accuracy, normal blood pressure later. 72 hrs after vaccine decreased white blood cells to 1.7 then trending back to normal, physicians thought viral infection not 2 vaccine, 1 week later, entirely back to normal.  10/26/06 Received medical records from hospital which reveal patient admitted 5/29/06 w/leukopenia, thrombocytopenia & history of EBV infection 3/06. Patient had fever, chills & severe malaise. Consults by hematology & infectious disease were done which revealed dx: process possibly secondary to EBV, possible connective tissue disorder & other viral infection including DMV & HIV.  Heme reviewed blood smear & found atypical lymphocytes w/o blastic forms.  Heme thought process related to acute EBV infection recently.  ID recommended rechecking labs. CT was to be scheduled. Patient reported that symptoms from EBV had been improving until received menomune vax 5/26. PMH: exercise induced asthma, acne, mono 3/06.  Hospital Course: temp max 103, decreased appetite.  On doxycycline for several years for acne which was d/c as possible cause of aplastic anemia.  10/27/06 Received t/c from hospital med records dept which stated patient admitted on 5/29/06 & d/c on 5/30./ss 10/26/06 Received medical records from PCP which reveal patient seen 3/10/06 wfever & body aches.  Strep test neg. Dx: mild pharyngitis, mild rash.  Patient not improved by 3/15.  Parent requested mono test on 3/21. 10/30/06 Received note from hematologist that all medical records were part of the hospital records/ss
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-Mar-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-Mar-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-Mar-2022) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2022 at 3:08 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment details were provided.   This case was linked to MOD-2022-542869 (E2B Linked Report).; Sender's Comments:  MOD-2022-542869:Master Case
Fatigue; chills; achy; This is a spontaneous report from a contactable consumer, the parent. A 17-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 19Mar2021 at 09:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and allergy to (ZOFRAN). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included multi-vitamins (unspecified). The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 08:00, the patient experienced fever, chills and achy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events fever, chills and achy were resolved on an unknown date.   No follow-up attempts are needed. No further information is expected.
It started with sore throat, cough, headache, slight fever and then I progressed to being so dizzy and off balance. Now, I have total nausea and diarrhea. I feel very fatigued. My doctor subscribed PAXLOVID for 5 days. I have shortness of breath if I move around.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient experienced symptoms for few minutes and was resolved within 20 minutes of injection
52-year-old man with significant known history for dyslipidemia/diabetes mellitus had complaint of myalgia, fever, chills and SOB.  Diagnosis: Pneumonia, hypotension, hypoxia and COVID-19. Treatment: Oxygen, remdesivir, Decadron, Levofloxacin. Discharged home.
pt recv vax 06MAY92 & 06JUL92 lab eval revealed anti-HBS neg; No further details were provided;
Redness and swelling at and near the site. Some tenderness, itching and warm. Became worse the following day.
This spontaneous report was received from a pharmacist refers to a 13 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-JUL-2017, the patient was vaccinated with GARDASIL 9 (strength, dose, frequency, route of administration, lot number and expiry date were not reported) for immunisation. On 14-AUG-2017, the patient experienced severe neck pain (disability) and head pain (disability) the patient seek medical attention went to hospital. The patient spent 3 hours in the emergency room where unspecified labs were taken and the patient was prescribed an unspecified pain medication. The reporter stated that this was a significant disability for the patient as she was stating her head and neck pain were excruciating. The reporter stated that the patient was feeling better the pain was not as bad but she still has some lingering effects. The outcome of neck pain and headache was reported as not recovered. Causality assessment was not reported for the events.
Pt called pharmacy about 8:30pm to report bilateral injection site reactions. Pt reports swelling measuring approx. 8" in diameter around each injection site. Pt does not report any generalized or other localized s/sx at this time.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant medications was reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot# L035276 with expiration date 09-JUN-2017 and lot# L037924 with expiration date 22-JUN-2017 (dose and anatomical location were not provided). No adverse effect were reported. This is one two reports received from the same reporter. Additional information has been requested.
Diarrhea  and upset stomach lasting approximately 4 hours. Symptoms were gone by 7 pm. No known suspicious foods consumed. Not positive it was connected to the vaccine, but timing and short duration makes it seem likely. No treatment sought other than not eating for several hours.  Also, pain / tenderness at injection site lasting approximately 36 hours. No treatment sought.
A little swelling but it didn't last very long; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 26Feb2021 (Lot number: EN6203) at the age of 78 years as dose 2, single and administered in arm left, administration date 05Feb2021 (Lot number: EN9581) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "sinuses" (unspecified if ongoing), notes: she does take Flonase or Nasonex for her sinuses; "allergies" (unspecified if ongoing). Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE] taken for sinusitis; NASONEX taken for sinusitis. Past drug history included: Antibiotic, reaction(s): "allergic to a lot of antibiotics". The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset Feb2021, outcome "recovered", described as "A little swelling but it didn't last very long".  Follow-up attempts are completed. No further information is expected.
A spontaneous non serious report of stuffy nose, fever, green mucus coming out of her nose and coughing was received from the patient's mother concerning a 21-month-old female patient subsequent to accidental exposure to FLUMIST. This case in submitted in accordance with post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history included a similar reaction when the mother's roommate received FLUMIST last year. Concomitant medications were not reported. The patient did not receive FLUMIST. On 01-Dec-2008, her father received FLUMIST. Twenty-four hours later, the patient developed stuffy nose, fever, and coughing. On 02-Dec-2008, the patient had green colored mucus coming from her nose. The events of stuffy nose, fever, and coughing were ongoing. Follow-up Information 23-APR-2009: No additional information available. Reported refused to be contacted.
Shot given 08/07/2003- arm was greatly swollen.  08/07-08/11: also red and hot.  Patient had headache much of this time.  By 08/11 patient began to have a rash.  Took patient do doctor.
Headache; Coughing; Fatigue/Tiredness; she doesn't have energy; Bacterial globules in her lungs; Tested positive for COVID; This is a spontaneous report from a contactable consumer reporting on behalf of the patient via a Pfizer sponsored program. A 47-year-old female patient (sister) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 24Apr2021 (at the age of 47 years old) (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. Medical history included obesity (most likely 200 lbs) and hives. Concomitant medication included unspecified steroids for hives problem. The reporter stated that her sister got her first Pfizer COVID vaccine on 24Apr2021 and about days later, her sister tested positive for COVID on 30Apr2021 and schedule the get the second dose on 15May2021 this month and wanted to know if the patient should get it. The patient still has tiredness and she doesn't have energy to make a call. The reporter did not know if her sister has taken Tylenol or anything. The reporter know that the patient had headache, bacterial globules in her lungs, fatigue, and coughing.  The patient had lab test at her hospital where she works, she had one when tested negative and when she had second one tested positive on 30Apr2021. The patient had not yet recovered from fatigue/tiredness and she doesn't have energy, while outcome of the remaining events was unknown.   Information on the lot/batch number has been requested.
Information was received on 25-JUL-2016 from a lawyer regarding a case in litigation. The patient is a seventeen year old autistic who on an unknown date experienced vaccine-induced autism. On 10-JUL-2000 the patient was vaccinated with M-M-R II. It was reported that medical records on 10-JUL-2000 showed the patient received a series of vaccines and began to regress into autism. Upon internal review, vaccine-induced autism was determined an important medical event. Additional information has been requested.
LEFT ELBOW PAIN AND PAIN FROM SHOULDER TO WRIST; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, alcohol use, and smoker, and other pre-existing medical conditions included the patient had no known allergies and did not have drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAR-2021, the subject experienced left elbow pain and pain from shoulder to wrist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left elbow pain and pain from shoulder to wrist. This report was non-serious.
Information has been received concerning a patient who on an unspecified date was vaccinated with PNEUMOVAX 23 (lot# not provided). Subsequently on an unspecified date the patient experienced redness at injection site. No further information was available. Additional information has been requested.
Approximately 5 mins after receiving Moderna vaccine, pt was placed in the Recovery Observation Room. She began complaining of chest tightness and feeling throat closing up. Physician was called to area. He found her lying  flat on her back due to difficulty breathing, Lungs clear to auscultation, no facial or lip swelling noted. Pt informed the staff the first time that she has multiple allergies but could only recall Wheat and Latex (and that they cause similar reactions). EpiPen was administered with her permission in left lateral thigh. Within 15 seconds, pt reported her symptoms had resolved. Pt refused ambulance, refused to sign AMA form. 10 min after injection, pt reported feeling good but "jittery." Prior to discharge, pt was counseled on S/s requiring ER visit. Was given additional dose of Benadryl 50 mg PO.
Client received two doses of Janssen vaccine. First dose received 03/29/21 and second dose received 05/07/21. No side effects reported.