chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. E11A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN (Body ache). At the time of the report, PAIN (Body ache) outcome was unknown.            No relevant concomitant medication was reported.  Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: F/U received on 29-APR-2021,TCR, added demographics. updated actions- Patient denied FU.
Mild soreness in the vaccination site; Initial information regarding an unsolicited valid non-serious case received from a Consumer via other (email) from on 22-Dec-2020.  This case involves patient of unknown demographic detail who had mild soreness in the vaccination site (Vaccination site pain), while the patient received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient stated that she had one INFLUENZA VACCINE, and experienced mild soreness in the vaccination site (Vaccination site pain).  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Varicella - information has been received from a registered nurse concerning a male child who on 27 apr  2000 was vaccinated with one dose of varicella virus vaccine live (unknown site).  On 01 May 2000 the patient developed varicella.   The patient sought unspecified medical attention.  Additional information has been requested.
Diarrhea; Fever(101.00F to 102.5F); This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA and PYREXIA (Fever(101.00F to 102.5F)) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.   No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced DIARRHOEA (Diarrhea) and PYREXIA (Fever(101.00F to 102.5F)). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Fever and Diarrhea, at an unspecified dose and frequency. On 19-Mar-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, PYREXIA (Fever(101.00F to 102.5F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 101 f (High) 101.00 F to 102.5 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not provided.
5 DAYS POST VACCINATION, PEA SIZED RED SPOT ON ARM. 7 DAYS POST VACCINATION, RED SPOT SIZE OF LEMON, TENDER TO TOUCH, NOT ITCHY, NOT PAINFUL WHEN RAISING ARM. REFERRED HER TO PHYSICIAN FOR FURTHER EVALUATION.
Rash/hives developed on left inside forearm, then right forearm same day.  Rash/hives appears on upper arms and wrists after a couple days.  Rash developed in the groin /genital area after one week then along the belt line a bottom after about a week and a half.  After two weeks rash/hives started on legs. After 2 1/2 weeks rash stared on the fingers.  After over 3 weeks and 3 days (today), rash continues, but is not as itchy on the arms.
she continued to not feel well; low grade fever to 99.0; the day after that she developed a sore throat; stuffy nose; mild cough; This is a spontaneous report from a contactable consumer (patient's parent). A 13 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW978) via an unspecified route, administered in Right arm on 08Jun2021 (13-year-old at vaccination) as a Dose 2, single for COVID-19 immunization. The patient was non-pregnant at time of vaccination. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. Facility type vaccine was reported as pharmacy or drug store. The patient was not diagnosed with Covid prior to vaccination. The patient was not tested for Covid post vaccination. The patient had not received any other vaccine in four weeks of Covid-19 vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8734) via an unspecified route, administered in Right arm on 17May2021 (12-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. On 09Jun2021 (the day after the vaccination), the reporter's daughter developed a low-grade fever to 99.0, which responded to ibuprofen, the day after that she developed a sore throat, stuffy nose and mild cough, with a very low-grade fever. On 10Jun2021, she continued to not feel well the next day with similar symptoms, and then started to become slightly better by the 4th day after the shot. By the 5th day, today she felt almost well. The patient underwent lab tests and procedures which included body temperature: 99.0 (units unspecified), low grade fever on 09Jun2021.No treatment medications were received for the events sore throat, stuffy nose, cough and not feel well. The outcome of the events was recovering.  Follow-up attempts are completed. No further information was expected.
I fainted. I didn't know where I was. My brother laid me on the bed to lie down. My blood pressure was extremely low so he called our sister who is a doctor. She said to not take me to a doctor but to just lie down and make sure that I ate something. My sister came over and after that I don't know what else happened because I was out of it. I had slept for 3 days. Then I was able to get up and walk around, but I still felt ill. At about 5 or 6 days I started to feel normal. My blood pressure was normal, and then I could eat again. I believe I had omicron. Me and my sister in-law and niece were all positive for Covid-19. A couple days later is when I had those symptoms and became ill.
severe pain in her right ear cartilage; This is a spontaneous report from a contactable consumer(the patient).  A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3246, expiration date Apr2021), via an unknown route of administration, on 19Jan2021 at 13:45 (at the age of 68-years-old)  as a single dose in the right arm for COVID-19 vaccination.  Medical history was reported as "none." The patient was administered the vaccine in a clinic. The patient's concomitant medications were not reported. The patient had not received any other vaccines within four weeks prior to the vaccination. On 21Jan2021 at 16:30 the patient experienced severe pain in her right ear cartilage which she stated hurt unbelievably.  The patient took an aspirin and Benadryl and went to bed, but the pain woke her up about every fifteen minutes throughout the night. She stated that as of the reporting date it was eighty percent better.  The clinical outcomes of pain in ear was reported as recovering.
Patient awoke feeling lightheaded the day after vaccine with body aches, chills, felt warm, diaphoresis, nausea. Today (2 days after) feels a little better, but still dizzy.
hasn't had her period in almost 3 months; hasn't had her period in almost 3 months; This is a spontaneous report from a contactable consumer or other non hcp (patient) via a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 2 via an unspecified route of administration on 01May2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously, received PFIZER-BIONTECH COVID-19 VACCINE (Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on unspecified date as dose 1, single for covid-19 immunisation. This report was related to a study or programme. On an unspecified date, the patient experienced "she hasn't had her period in almost 3 months." The patient wanted to know if that was a normal side effect. She had also stopped breast feeding. Seriousness of the events were provided as unspecified by reporter. NDC number of PFIZER COVID 19 vaccine was not provided. Investigation assessment was not provided. Outcome of the events was unknown. Information on the lot/batch number has been requested
3 hrs p/1st DTP pt devel hypotonic, hyporesponsive lapses turned limp & blue for few seconds mom gave mouth to mouth breathing responded well;
she also fainted; her blood pressure drops drastically on Sunday morning; This is a spontaneous report from a non-contactable consumer.  A consumer reported that a 94-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) on an unknown date at a single dose for COVID-19 immunization. Medical history and concomitant drugs were not reported. The consumer reported that the patient had the vaccine on 'Saturday' and on Sunday morning her blood pressure drops drastically, they called the doctor, she was under in doctor's hand, she called the doctor again today, she also fainted. The consumer was questioning if it can in very extreme cases cause the blood pressure to go havoc. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained
COLD; FEELING COLD; ARM PAIN; CHILLS; FEVER OF 101.3; This spontaneous report received from a consumer concerned a 20 year old male. The patient's height, and weight were not reported. The patient's past medical history included 3 strokes, and concurrent conditions included disabled. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced feeling cold. On 03-APR-2021, the subject experienced cold. On 03-APR-2021, the subject experienced arm pain. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced fever of 101.3. Laboratory data included: Body temperature (NR: not provided) 101.3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever of 101.3 on 04-APR-2021, was recovering from feeling cold, and had not recovered from cold, chills, and arm pain. This report was non-serious.
This spontaneous report as received from a pharmacist refers to an unknown number of patients of unknown age and gender. The pharmacist reported that unknown number of patients might have received ZOSTAVAX (lot number unspecified) that was improperly stored from 20-MAY-2013 to 05-JUN-2013. No adverse effects reported. It was unknown if the patients had sought medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Follow up information has been received from a health professional refers to a 63 (also reported as 64) year old patient (gender was unknown). On 08-NOV-2012 at 08:37 the patient vaccinated subcutaneously in right arm with a dose of ZOSTAVAX (lot number reported as H01148, exp. date not reported) (dose not reported) which was incorrectly stored. No adverse reactions reported. This is one of several reports from same source. Additional information is not expected.
Breakthrough case admission after 3 vaccines Moderan 2/3/21 Lot# 038K20A;  Moderna 3/3/21 Lot# 030A21A;  Moderna 11/10/21 NO LOT #   LOT NUMBER IS NOT IN DATABASE
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 24-SEP-2015, the patient was inoculated with ZOSTAVAX at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. 12-DECEMBER-2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed valacyclovir (VALTREX) for management of his painful symptoms. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Patient's daughter called after the event and reported that patientexperienced wheezing, cough and syncope "later that day" after he returned home from flu clinic.  She did not indicate which, if any, hospital he was taken to, but that she had called his physician. Cardiologist.  She reported that her father died on Sunday 10-21-2007 11/6/07 Received hospital clinic & cardiology medical records which reveal patient experienced CAD, s/p CABG (1982 & 1990) & severe LVD s/p ICD biventricular deployment; chronic back problems; hyperlipidemia; diabetes type 2; & controlled HTN.  Cardiac cath of 4/2006 revealed patent left internal mammary arter to LAD bypass graft w/other grafts being occluded.  Had been hospitalized 7/07 for pacemaker device discharge.  Had DOE at that time.  Pacer rate was increased due to myocardial ischemia.  Developed chest pain, nausea & additional DOE.  Dx w/unstable angina 7/11/07 & admitted to hospital.   1/18/08 Reviewed ER records of 10/22/07 which reveal patient fell & had witnessed cardiac arrest at home 50 min prior to arrival in ER.  Had been intubated & IV access placed in field.  ECG revealed V-fib & then asystole & patient expired 10/22/07. 1/29/08 Cardiac arrest per death certificate.
Information has been received from a health professional concerning a 21 year old female who on 25-JUL-2007 was vaccinated IM in the left deltoid with the first dose of Gardasil (lot# not reported).  On 25-SEP-2007 the patient was vaccinated IM in the right deltoid with the second dose of Gardasil (658560/1062U).  Subsequently the patient experienced localized redness at the injection site.  The patient did not have any shortness of breath, pain or other symptoms.  On 07-JAN-2008 the patient came to the clinic for her son's visit and had a small, white circle around the injection site.  It is not itchy or painful and there are no other problems.  There were no problems reported following the first vaccination with Gardasil.  No other information is available.  Additional information has been requested. Additional information received from B-form (17-MAR-2008): the patient stated that she had a "ring" on her arm - no raising, no itching. Pain was present post-injection for the initial day and then there was no more pain. Additional information is not expected.
Case number PHEH2016US029328 is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 61 year old male patient. Medical history and concomitant medication was not reported. The nurse stated that first temperature excursion of FLUCELVAX Quadrivalent on 18 Oct 2016 at 52 Fahrenheit (F) for 1 hour, second excursion of FLUCELVAX Quadrivalent on 23 Oct 2016 dropped low 6 times to 34 Fahrenheit (F) and lasted 30 minutes each time, it was unknown if vaccine was frozen. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: not reported) at a dose of 0.5 ml intramuscularly on 31 Oct 2016. Third time excursion on 02 Nov 2016 down to 32 Fahrenheit (F) 3 times over the course of 12 hour it was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this administration error.
On 05NOV2010, a 26 year old male, was vaccinated with BIOTHRAX by subcutaneous route to an unknown arm. On 06Nov2010, the subject complained of swelling of the arm at the injection site. On 07Nov2010 the subject complained of pain with limited mobility of the injection site arm. 08NOV2010, he was seen by a medical provider and subsequently diagnosed with cellulitis. He was treated with an unspecified antibiotic and told to return in 24 hours if there was no improvement. At the time of report, the outcome was unknown. Additional information was received on 02DEC2010 which revealed the subject recovered well, and without lasting effects.
Chills,  muscle aches, headache & nausea and sore at the arm site were the symptoms.  Time was approx 8:30 when chills began and this was the second dose of Pfizer vaccine.   Took acetaminophen with the onset of discomfort.
injection site pain; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on 08Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced injection site pain on an unspecified date but did not bother to report as she thought it "wasn't worth reporting". She is scheduled for her second dose on 25Mar2021 (17 days after dose 1) and the patient was asking if this would be valid. The outcome of the event was unknown.    No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Small dots size of a freckle, red, all over body. Started at shot site, right leg. Went to ER and was told reaction to the shot. Also had fever at 104.
Patient came to the ED with complaints of shortness of breath requiring the use of oxygen via nasal cannula.  Patient admitted for Covid pneumonia and treated with remdesivir.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent condition and medical history reported. On an unknown date, the unspecified number of patients were vaccinated with improperly storage MMR II (dose, route of administration, lot# and expiration date not reported). There was no adverse effects reported. Additional information is not expected. This is one of several reports received from the same reporter.
little red bumps over her legs / red dots were diagnosed as Pleva; allergic hives / on the back of her legs / hives were due to a drug or food interaction; allergic hives; red bumbs; red bumps; drug or food interaction; This case was reported by a consumer via call center representative and described the occurrence of hives in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had the first case at age between 11 and 13 and the second case at 42 years of age.).   On 27th July 2020, the patient received the 1st dose of Shingrix. On 14th August 2020, 18 days after receiving Shingrix, the patient experienced hives, pityriasis lichenoides, allergic reaction, erythema and swelling. In August 2020, the patient experienced food interaction. On an unknown date, the outcome of the hives, pityriasis lichenoides and allergic reaction were recovered/resolved and the outcome of the erythema, swelling and food interaction were unknown.   It was unknown if the reporter considered the hives, pityriasis lichenoides, allergic reaction, erythema, swelling and food interaction to be related to Shingrix.  Additional information was provided as follows: On 14th August 2020, the patient experienced allergic hives that broke out on the back of her legs and little red bumps over her legs. On 17th August 2020, she saw a dermatologist who biopsied the hives and bumps.  She confirmed that the hives were due to a drug or food interaction and red dots were diagnosed as Pleva. Her symptoms resolved and she planned to get the second dose of Shingrix day after reporting.  She had no known allergies and no breaks outs prior to receiving the Shingrix vaccine. The reporter consented to follow up.
Pain initially started in injection site on right upper arm/shoulder.  Now, sharp pains occur near injection site, upper arm and neck.  I have a hard time lifting my arm much more than waist height.  Lifting above my head causes severe pain.
Patient stated that she felt a burning, radiating sharp pain in upper right arm the first 2 days upon receiving the vaccine. By the 4th day, she developed a red raised bump at the injection site approx 4" in diameter. Pt applied heat and took Tylenol as instructed by her physician. Bump began to "ooze" for several days (pus-like fluid). After several days, bump decreased in size and began to "crust" and peel around edges. Injection area remained slightly tender and warm x 2 days.
This spontaneous report was received from a physician refers to a multiple patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date in January 2016, the patients were vaccinated with improperly stored dose (temperature: 33.7 F, time frame: 1 hour) of GARDASIL (lot # K010215, exp. 05-MAY-2017, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from same reporter link. Additional information has been requested.
sore arm, sinus congestion, headaches for 4 days  Narrative:  Other Relevant History:
Pt seen 2/6/17 for well child and vaccines, returned 2/13/17 with petechiae to lower extremities and zero platelets-diagnosed as ITP-treated once with IVIG for nosebleed-requiring ongoing labs and specialty appts.
This spontaneous report was received from a nurse via a company representative referring to a currently 21 years old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 21-DEC-2017, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly, for prophylaxis (dose, lot # and expiration date were not reported) without any problems. On 28-FEB-2018, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly, lot # N022584 with expiration date 15-JUN-2020, for prophylaxis. On an unspecified date in 2018, after the second GARDASIL 9 vaccination, the patient passed out (loss of consciousness) at her beautician's office. The patient was seen at the emergency room and was released on an unspecified date in 2018 and was advised to follow up with a cardiologist. The patient reported to her physician that she was seen at the cardiologist and "everything was negative". Additionally, the patient was seen by an unspecified neurologist on an unspecified date in 2018 (no details were provided). At the time of reporting, the outcome of the event was unknown. The causality assessment between the events and GARDASIL 9 was not provided. Upon internal review, loss of consciousness was determined to be a medically significant event.