chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a 16 year old male patient. Medical history and concurrent conditions were not reported. On 21-JUL-2014 at 5:00 pm the patient was vaccinated with the second dose of (Merck) VARIVAX (lot# J012973, expiration date 15-OCT-2015, subcutaneous in the left arm). The vaccine was improperly stored. No adverse symptoms reported. This is one of four reports received from the same reporter. Additional information is not expected.
Child awoke this morning, the day after her well visit and vaccine administration with hives on her body. Otherwise completely well. Parent gave Benadryl and rash resolved. Pt doing well. No other symptoms.
an expired Pentacel vaccine was given to two siblings/ No AE; Initial information was received on 30-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves 2 patients (demographics unknown) who were vaccinated with a 0.5 ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Lot no:UJ097AAA and expiry date : 19-Sep-2020, strength: standard) once via unknown route in unknown administration site on 30-Sep-2020 for prophylactic vaccination (expired product administered).  The patients medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  This was an actual medication error case due to expired vaccine used (latency was same day).  An expired doses of Pentacel were given to two siblings by accident. There was no information on the patients other than they were siblings and very young. Only the box was remaining and the vials had been discarded.  At the time of reporting, no adverse event 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Migraines went from a few a year to multiple per week continuing until present. Blood pressure went from normal to high (systolic formally 110?s, went up to 150?s).
felt like she was burning up but temp was 98.0, arm hot at site and red, swollen and ache
Pt. states after receiving the J&J vaccine 05/05/2021, noticed 06/01/2021 that her tonsils had disappeared. Consulted with Primary 06/28/2021 with no recommendations nor explanation.
Initial report received on 09 October 2007 from the patient.  54-year-old male patient, with no illness at the time of vaccination, had received a first dose, left deltoid, intramuscular injection of Adacel, lot number unknown; and a second dose, right deltoid, intramuscular injection of Fluzone SV 2007-2008, lot number unknown; on 01 October 2007. Three days post-vaccination, the patient experienced swelling of his fingers, mouth, throat, and tongue. He had no shortness of breath. He was examined by a physician four days later, and the swelling had decreased although his feet, arms, and mouth were still swollen. The patient was treated with cortisone and was to follow-up with an allergist. Relevant diagnostic testing was none. At the time of this report, the patient had not recovered.
Dose 1 received 5 March 2021. Dose 2 received 2 April 2021.  About 2 weeks after dose 2, patient began experiencing painful swelling and stiffness of joints (knees, ankles, wrists, elbows). No injury event, change in diet, or additional contributing factor noted. Due to symptoms, patient was unable to perform normal daily activities and sought care form primary care doctor. Pain management was attempted with acetaminophen. Symptoms continued for 3 months and eventually self-resolved.  At the initial date of this report (21 December 2021) patient has not received additional doses.
Nausea; migraines; fever; cough; pain; swelling; reflux; The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Jun2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: EXCEDRIN ASPIRIN FREE; TYLENOL; ADVILCAPS; IBUPROFEN. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right, Vaccine Administration Time: 08:00 AM), administration date: 06Jun2021, for Covid-19 immunisation; BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 17May2021. The following information was reported: NAUSEA (non-serious) with onset 11Jun2022 at 20:00, outcome "unknown"; COUGH (non-serious) with onset 11Jun2022 at 20:00, outcome "unknown"; PYREXIA (non-serious) with onset 11Jun2022 at 20:00, outcome "unknown", described as "fever"; MIGRAINE (non-serious) with onset 11Jun2022 at 20:00, outcome "unknown", described as "migraines"; PAIN (non-serious) with onset 11Jun2022 at 20:00, outcome "unknown"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset 11Jun2022 at 20:00, outcome "unknown", described as "reflux"; SWELLING (non-serious) with onset 11Jun2022 at 20:00, outcome "unknown". Therapeutic measures were not taken as a result of nausea, migraine, pyrexia, cough, pain, swelling, gastrooesophageal reflux disease. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
She is having a little fatigue problem; This is a spontaneous report from a contactable consumer. This consumer (husband) reported for a female patient (wife) that:  A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced fatigue. Reporter's wife got the second dose of COVID-19 Vaccine on Sunday. The patient is having a little fatigue problem. The outcome of the event was unknown.    No follow-up attempts are possible. Information about lot/ batch no cannot be requested.
No adverse events occurred. Patient was given 0.25mL instead of recommended 0.5mL
Sore arm, fever 103 degrees, H/A, body ache.  Started 5.28.08 at noon thru 6.29.08.
Swelling to right thigh area and painful to site (R) thigh area - localized reaction.
Did not feel like doing anything; Weak; Depression; I wasn't myself it wasn't me a 100% and it took more than a month to act like myself again; Aches and pains; Shivers; Headache; Fever, 100.1°F; Did not want to eat/had problems eating; Had the burns; For 3 days could not open eyes; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENOPIA (For 3 days could not open eyes), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Did not feel like doing anything), ASTHENIA (Weak), DEPRESSION (Depression) and DECREASED APPETITE (Did not want to eat/had problems eating) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided.     On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced ASTHENOPIA (For 3 days could not open eyes). 01-May-2021, the patient experienced DECREASED APPETITE (Did not want to eat/had problems eating), THERMAL BURN (Had the burns), MYALGIA (Aches and pains), CHILLS (Shivers), HEADACHE (Headache) and PYREXIA (Fever, 100.1°F). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Did not feel like doing anything), ASTHENIA (Weak), DEPRESSION (Depression) and FEELING ABNORMAL (I wasn't myself it wasn't me a 100% and it took more than a month to act like myself again). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHENOPIA (For 3 days could not open eyes), DECREASED APPETITE (Did not want to eat/had problems eating), THERMAL BURN (Had the burns), MYALGIA (Aches and pains), CHILLS (Shivers), HEADACHE (Headache) and PYREXIA (Fever, 100.1°F) had resolved and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Did not feel like doing anything), ASTHENIA (Weak), DEPRESSION (Depression) and FEELING ABNORMAL (I wasn't myself it wasn't me a 100% and it took more than a month to act like myself again) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2021, Body temperature: 100.1 (High) High. On 01-May-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Cholesterol Medications, Blood pressure Medications, Anxiety and Depression Medications were used as concomitant Medications. Patient drank chamomile tea.   This case was linked to MOD-2021-299708 (Patient Link).
I had a low-grade fever, runny nose, a really bad headache, I used a home COVID-19 test that came back positive. I called my doctor to consult with her about my positive test and symptoms, she prescribed the PAXLOVID. I started taking the medication, I was feeling better within the five days of taking the course of the medication. Three days after finishing the medication I started feeling bad again, I started having a croupy cough. I stayed in quarantine; I wore a mask when no one was home walked to the front door to go outside walked around the neighborhood to get my lungs to take the deep breaths. In total I was in quarantine for a total of 21 days. My strength is returning, and I feel I have recovered fully.
pt recv vax & exp scattered pruritus & sl maculopapular rash;It was noted that pt had no sx following vax;
Pt was given shot on 12/1/18 with no S/E. On 12/9th, when pt was about to go to bed, she noticed rash on left part of  her neck with no pain. The rash gradually spread over a course of a few days  to the  left arm, left ear, left side of chest and back. She felt stabbing/throbbing pain on her left ear and left part of her head. Pt went to her PCP on 12/11/18 and was given prednisone and acyclovir. The pain has subsided since then but she still has some rash.
This spontaneous report was received from a medical assistant refers to a 19-year-old female patient. On 06-NOV-2012 the patient was vaccinated with dose 3 GARDASIL (lot # not reported, expiration date 17-OCT-2012). No concomitant medications were reported. Patient was administered an expired dose of GARDASIL. No adverse effect reported. No further information is available. Additional information has been requested.
Arms are real sore; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (reporter's husband). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number unknown) via unspecified route of administration as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. The reporter stated that her husband had COVID shot and he had a large reaction and arm was real sore. The outcome of event was unknown.  Information about lot/batch number has been requested
Started with a headache the next morning around 10:00am then progressed throughout the day to a horrendous migraine similar to the effects of when I took immitrex and had the worst migraine in my life.  All day on the 20th, I felt lethargic and dizzy and would start blacking out when doing even light activity. In the evening, I got chills even being under the blankets and having the thermostat in my room up to 75F. I had a low grade fever at 100F, super fatigued, shortness of breath. Sunday the 21st  I was fatigued so much that with activity such as walking to my garden shed and getting chairs cause me to start blacking out. I had to sit for a moment to regain eyesight and even out to walk. This lasted through the 23rd of March, I had fatigue, brain fog, and shortness of breath. On the 24th and 25th I still felt fatigued but less brain fog. By the 26th of March I was feeling more myself. I am worried what the 2nd shot will do.
2nd dose should be on 28Dec but they missed the dose since the son got tested positive with the Covid virus; he tested positive without symptoms; 2nd dose should be on 28Dec but they missed the dose since the son got tested positive with the Covid virus; he tested positive without symptoms; This is a spontaneous report received from a contactable reporter consumer or other non Health professional for a Pfizer sponsored program. The reporter is the parent.  A 5 year-old male patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: FK5618; Expiration Date: Unknown) via an unspecified route of administration on 07Dec2021, as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. On an unknown date in Dec2021, the patient experienced 2nd dose should be on 28Dec but they missed the dose since the son got tested positive with the COVID virus; he tested positive without symptoms (DRUG INEFFECTIVE and COVID-19). It was reported that, a mother of of 5 years old son, called because 1st dose was given to the son on Dec 07Dec2021, 2nd dose should be on 28Dec but they missed the dose since the son got tested positive with the Covid virus and they called to ask when it's going to be time, he could get the 2nd dose after the positive testing and the reporter mentioned that this is the without symptoms, he tested positive without symptoms. On an unknown date in Dec2021 the patient underwent the laboratory tests and procedures included sars-cov-2 test result was positive. The clinical outcome of the events was unknown at the time of this report.  No follow-up attempts are possible. No further information expected.
The site of injection is hot and swollen; Redness and rash at the site of injection; Redness and rash at the site of injection; The site of injection is hot and swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (The site of injection is hot and swollen), VACCINATION SITE ERYTHEMA (Redness and rash at the site of injection), VACCINATION SITE RASH (Redness and rash at the site of injection) and VACCINATION SITE SWELLING (The site of injection is hot and swollen) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE WARMTH (The site of injection is hot and swollen), VACCINATION SITE ERYTHEMA (Redness and rash at the site of injection), VACCINATION SITE RASH (Redness and rash at the site of injection) and VACCINATION SITE SWELLING (The site of injection is hot and swollen). At the time of the report, VACCINATION SITE WARMTH (The site of injection is hot and swollen), VACCINATION SITE ERYTHEMA (Redness and rash at the site of injection), VACCINATION SITE RASH (Redness and rash at the site of injection) and VACCINATION SITE SWELLING (The site of injection is hot and swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Noticed large amount of swelling at injection site in the morning following the vaccination.  By the afternoon the swelling was most of her arm.  By the evening it began to include hives around injection site.  Next day she began running a fever.  Followed up with the Dr.  They noted fluid behind the ear on effected side.
Right after administering the immunization the patients head rolled back and his body started to convulse.  Put him onto the floor he stopped convulsing and went limp. As I was checking for a pulse he woke back up very disoriented. EMS was called they came and took him to the hospital
I had adverse effects immediately, but they were the normal things after getting the shot, like chills and fatigue. But then I thought it was my dog waking me up in the middle of the night. I was kind of foggy. I could not really tell when the adverse event started. I saw my PCP on 07/09/2021 for a regular physical. They did blood work, mammogram, bone density, which all came back normal. Then we made an appointment for the cardiologist. I have not received any treatment since I am waiting to see a cardiologist on 10/05/2021.
devel chills, became pale; "shaking all over", T102;mom took pt to ER 2OCT95 & given APAP; took to MD 3OCT94;both MD & ER stated allergic rxn to pertussis;
This male subject was enrolled in the prophylactic double blind study. On 10/14/04, he received the first dose of rotavirus vaccine or placebo. Concomitant vaccination included: On 10/14/04, combined diphtheria, tetanus, acellular pertussis, inactivated polio, haemophilus influenzae type B vaccine. This subject received a first dose of placebo vaccine. On 10/14/04, the day he received the first dose of blinded vaccine and Infanrix-IPV-HIB, this two month old subject had not passed stool. Usually he passes stool once or twice daily. On 10/17/04, the subject's mother contacted the study nurse complaining about child's constipation and was advised to keep observing. On 10/19/04, the subject was examined: no fever, normal urine output, no irritability and no abdominal distension were found. The temperature was taken by rectum (37C) and a small about of soft stool was seen. However, no stool had passed since 10/14/04. The subject was diagnosed as having constipation. On 10/20/04, he was treated with glycerin suppositories at the outpatient clinic with good results: a large amount of loose yellow stool passed out. The event improved. On 10/29/04, the subject was followed up again as he had passed stool only once on 10/25/04. Physical examination was done: the subject was well, abdomen was soft, no mass, rectal examination was normal. Mother was advised to monitor for 1-2 days more. On 10/31/04, the subject had passed a large amount of yellowish to green soft stool. He was active and playful. The mother was contacted on 11/8 and 11/17/04 and explained that the subject passed normal yellowish stool once or twice weekly. The investigator considered the event to be medically important since there was a significant changing bowel habit (OMIC). The investigator considered there was reasonable possibility that the constipation may have been caused by investigational product or concomitant Infanrix-IPV-HIB vaccine. The vaccine course has been discontinued.
Limp, fatigue starting 12/1, progressing to fevers, admitted for possible septic hip Later rash developed in the course of disease; fevered x 2 weeks, then rash and defervesced coincided with naproxen Elevated inflammatory markers, including ferritin Now a possible diagnosis of Juvenile Idiopathic Arthritis. vs parvovirus vs vaccine reaction (version of MIS-C?)
Extremely sore arm Body aches all over Severe chills  Headache Nausea Fatigue
This spontaneous report received from a medical assistant concening a 1 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 03-MAY-2017, the patient  received improperly stored dose of VARIVAX (dose, frequency not reported) (Lot: M041513, expiry date: 11-OCT-2018) reconstituted with sterile water diluent (unknown lot number and expiration date). Temperature and Time frame: -14°C to -10°C for 9 hours 43 minutes, -14°C to -10°C for 15 hours 46 minutes, -14°C to -10°C for 12 hours 31 minutes. Previous temperature excursion was -14°C to -10°C for 6 hours 26 minutes. The call was because of data logger. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA000291: US-009507513-1706USA000288: US-009507513-1706USA000289: US-009507513-1704USA014383:
While in the observation room after receiving Moderna vaccination, member complained of chest tightness; she denied difficulty breathing/shortness of breath, was alert and oriented and did not appear to be in respiratory distress (also no itching, hives, rashes, or other complaints at the time); manager on duty was also present. Blood pressure, heart rate,  and oxygen saturation were 250/87, 76, and 100% (room air), respectively (4:55 pm). 911 was called (4:55 pm). Blood pressure was repeated at 5:00 pm (230/77) and 5:03 pm (221/159); oxygen saturation remained at 100%. At 5:04 pm, member started to complain of lightheadedness and EMS arrived at that time. Member was placed on the stretcher and transferred member to the Hospital. Note: Member has hypertension and stated she did not take her medication today.
arm is sore; A spontaneous report  was received from a consumer concerning a 56 year-old female patient who received Moderna's COVID-19 Vaccine and experienced sore arm .  The patient's reported medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received the first of two planned doses of mRNA-1273 intramuscularly for COVID-19 for infection prophylaxis.  On 04 Jan 2021, the patient stated that her arm was sore and that it was probably because of the weather. The patient would get the second injection on 22 Jan 2021. No treatment information was provided.  Action taken with mRNA-1273 in response to the events is not applicable. The outcome of the event, arm is sore, was considered unknown.  The reporter did not provide causality for the event.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report was received from a company representative concerning a 5 year old 9reported as 5 years and 2 months of age) female patient. On 03-DEC-2012, the patient was vaccinated with a dose of VARIVAX (lot number reported as 11011416, expiry date unspecified) (dose, route unspecified). No concomitant medications were reported. On 03-DEC-2012, the patient developed 2 vesicles on the arm swollen and red, a few hours after the administration of the vaccine. Patient sought medical attention (unspecified). She was treated with TYLENOL. It was unspecified if the laboratory diagnostic tests were performed. The outcomes of the events were unknown. Additional information has been requested.
12-20-10 Pt reports projectile vomiting, 1/2 hr after feeding - 3-4 x day.