chrisvoncsefalvay/vaers-outcomes huggingface dataset:
OCCASIONAL CRAMPING SPECIFICALLY IN THE CALF MUSCLES/ LEGS - SYMPTOMS OF CRAMPING; LEGS-NUMBNESS; FEELING OF LEGS TIREDNESS; LEGS-WEAKNESS; WARM FEELING BUT NO FEVER - TEMP 99.0F; GENERALIZED BODY ACHES (NO SPECIFIC LOCATION OF PAIN); INJECTION SITE MINOR PAIN/ NO RASH OR MUSCLE PAIN; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, seasonal allergies, and non smoker, and other pre-existing medical conditions included patient does not have medical history and not taking prescribed medications .the patient does not have history of illicit drug abuse. patient does not experienced headache, fever, nausea. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 10-JUL-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for drug used for unknown indication. On 10-JUL-2021, the subject experienced warm feeling but no fever - temp 99.0f. On 10-JUL-2021, the subject experienced generalized body aches (no specific location of pain). On 10-JUL-2021, the subject experienced injection site minor pain/ no rash or muscle pain. Laboratory data included: Body temperature (NR: not provided) 99.0 F. On 15-JUL-2021, the subject experienced occasional cramping specifically in the calf muscles/ legs - symptoms of cramping. On 15-JUL-2021, the subject experienced legs-numbness. On 15-JUL-2021, the subject experienced feeling of legs tiredness. On 15-JUL-2021, the subject experienced legs-weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from warm feeling but no fever - temp 99.0f, generalized body aches (no specific location of pain), and injection site minor pain/ no rash or muscle pain on 11-JUL-2021, and had not recovered from occasional cramping specifically in the calf muscles/ legs - symptoms of cramping, legs-numbness, feeling of legs tiredness, and legs-weakness. This report was non-serious.
Moderna administered in error to 17 year old female.  No adverse effects are noted at this time.
Rash; This spontaneous case was retrieved on 01-Feb-2021 reported by other health professional and concerned a 35-year-old, male patient.  The patient's medical history and concomitant medications were not reported.  On 27-Nov-2018, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; anatomical location: left arm, route of administration, dose and indication: not reported). The batch number reported was YF42409.   On the same day, after receiving Afluria Quadrivalent, the patient experienced rash.   The outcome of the event was not reported.  The reporter did not provide a causality assessment.   This case was assessed as non-serious.  Company comment: The event of 'rash' is assessed as related to Afluria Quadrivalent.; Sender's Comments: The event of 'rash' is assessed as related to Afluria Quadrivalent.
the patient had equivocal titer results for varicella in 2015, 2017, and 2018; This spontaneous report was received from a physician and refers to a 23-year-old male patient. The patient's concurrent conditions and concomitant medications were not reported. Medical history included history of drug reaction/allergy for azithromycin.  On an unknown date, reported as at age 12 months, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (dose, site, route of administration, lot number and expiration date were not reported) as routine vaccine series.  On an unknown date in 2015, 2017 and 2018, the patient had equivocal titer results for varicella. No treatment was given for the event.   The outcome of the event was unknown (also reported as "Present status: healthy"). The causality between the event and the suspect vaccine was not reported.
Hypertension, tachycardia, chest pain, severe myalgias with muscle weakness of lower extremities.
From August, 2000, to present 4/01 have had fatigue; aches; headaches; joint pain (all joints); nerve pain; fevers; now, extreme pain in joints and nerve spasms, constant fatigue and frequent headaches. Ongoing.
Four falls. Extreme upper and lower weakness. quadriplegia. Hospitalized for one month.  Diagnosed with AIDP/GBS. Given IV's. In wheelchair currently since April.
No adverse reaction - The patient presented to a Community Vaccine Event with a consent form signed by a guardian. The date of birth placed on the form by the guardian was  (12). When I went to enter information in MIIX, I discovered the Date of Birth of the patient was  (11) which is not able to receive the vaccination.
Pt went limp and loss consciousness- put pt in car to go to ER - In the car on the way started seizures
UTI; Second dose postponed 5 weeks from second scheduled dose; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Second dose postponed 5 weeks from second scheduled dose) and URINARY TRACT INFECTION (UTI) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 022M21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Heart disease, unspecified, Gout and Acid reflux (esophageal). Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), ALLOPURINOL for Gout, ASPIRIN [ACETYLSALICYLIC ACID] for Heart disorder, METOPROLOL SUCCINATE (TOPROL) and SPIRONOLACTONE for Hypertension, CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]) for UTI.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Second dose postponed 5 weeks from second scheduled dose). On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI). On 16-Apr-2021, INTENTIONAL PRODUCT USE ISSUE (Second dose postponed 5 weeks from second scheduled dose) had resolved. At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown. Not Provided          Concomitant medication include Flomad for Heart disease. Treatment Information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up information received on 14 Jul 2021 contains non-significant information.
Patient stated she got up to so to the restroom the evening she received her vaccine and had tingling in her hands, face, and toes.  Patient stated she urinated on her self on the way  to the restroom which is atypical for her.  Patient stated she was unable to move for 3 hours from the toilet.  Patient stated she was helped back to bed by her partner.  Patient stated she did not go to ER.  Patient was advised to call PCP for follow up.
Received H1N1 on 2/11/09.  5 days post shot, developed hot red sore arm and fever.  Symptoms remained up to 12/21/09, where slight reduction in intensity began.  Person used benadryl, ice and tylenol during symptoms.  Recovery is expected.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown ages and genders. On multiple unspecified dates, the patients were inadvertently administered with improperly stored PNEUMOVAX 23 (lot # L040181, expiry date: 18-AUG-2017; lot # M005287, expiry date: 08-OCT-2017). The vaccine was stored at a temperature of 9.9 UC at an unknown time frame. Data logger was involved and there was no previous temperature excursion. No adverse effect reported. The outcome of the events was not reported. Additional information has been requested.
Vax being given, pt drew away as vax being injected; consequently, vax was given SQ dribbled onto outer layer of skin; Pt withdrew because med began burning; skin became red & painful & burned; site inject elevated, red & tender;
Myalgia, pain to inj site; flu symptoms, fatigue, muscle/body aches, chills Narrative: Day 2 -noted pain to inj site; flu like symptoms, fatigue, muscle aches, body aches, chills; Day 3 - body aches
MGM called CCN on 5/5/03 and reported that the child's right leg was swollen due to shots received on 5/2/03.  Taken to IGH ER on 5/4/03 for swelling and fever.  Instructed by ER MD  to apply warm compresses and give motrin for fever.  MD diagnoesed abcess.  Instructed to bring to FCHD so nurse can assess.  Nurse assessed red swollen, and painful to touch where DTaP was administerd.  Nurse instructed mom to follow MD's instructions of compresses and motrin.
Pt reported pain, swelling, tenderness and weakness in arm that received vaccine.  Pt denied fever, numbness.
Started on 08/12/07 with little red bumps on the face and body. Mother administered Benadryl 1/2 tsp every 6 hours. On 08/13/07 the little red bumps spread to the rest of the body and they became severe red raised hives covering the face, in the hair, body, arms, vaginal area, legs, feet. She was running a slight temperature and mother administered 1.28 ml infant motrin every 4 hours. She was unable to sleep or wear any clothes because she would cry when anything touched her skin. Mother placed cool, wet cloths on her skin to cool her down and ease her discomfort throughout the night. She was also itching because patient was scratching her eyes and face with her hands and against her crib.  On 08/14/07, mother took patient to pediatrician where PA gave mother Zyrtec (1 tsp/once daily) to administer to patient.  Patient has been on Zyrtec for three days now and the hives are still visible on her face and the bumpy hives are still covering her entire body. Some of the red bumps have turned into open sores with a red scab on them.
pt was diaphoretic, c/o h/a & stated people talking sounded slow & very far away; treatment was diphenhyramic inject & observation;
mouth on left side drooped some; my lips started to swell and tingle; my lips started to swell and tingle; the left side of my face, from my jaw to the eye went partially numb; This is a spontaneous report from a contactable consumer (patient).This 48-year-old female patient received dose 2 of BNT162B2 (lot number ER8736) via an unspecified route of administration on 30Apr2021 at 14:15 (at the age of 48-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no known allergies. The patient previously received dose 1 of BNT162B2 (lot number ER8731) on 09Apr2021 at 15:30 as a single dose in the left arm for COVID-19 immunization. Approximately 35 minutes after the dose was administered (also reported as 30Apr2021 at 14:45) the patient experienced lips started to swell and tingle and the left side of her face from her jaw to the eye went partially numb. Her my mouth on left side drooped some.  It was similar to the sensation of numbness and drooping after receiving novacain at the dentist. The symptoms largely abated within one hour. The patient did not receive treatment for the events. The outcomes of lips started to swell and tingle, left side of her face went partially numb, and mouth on left side drooped some were recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19.
A rash in the arm where the vaccine was given. It started a week after I received the shot.
PT states that 2 days after receiving her second dose of Pfizer, she begin to have a rash that has now covered her entire body.   She is now covered in a itchy rash over her arms and L arm is hot. Zyrtec daily 10mg and that helps to relieve the itchiness.   RN has recommends she contact her doctor for further evaluation, continue to take the Zyrtec and try cortisone cream until she has an appt. Pt states her Dr. appt is Monday 04/12/21 @ 12:00pm.  reports taking zyrtec with hives resoled but the rash remains. recommended an additional antihistamine if needed such as benadryl or claritin. caller verbalized understanding. informed of worsening symptoms to seek a local ER like SOB, swelling to face, etc caller verbalized understanding
fever; fainting spell; fatigue; cough; headache; myalgias; Case reference number MOD-2021-013971 is a spontaneous case report sent by a Physician on 25-JAN-2021 00:00:00 , which refers to a Female aged 52 Years .  On 24-Dec-2020  the patient took Moderna COVID-19 vaccination. Some  2 days later,  the patient developed fainting.  The next day of vaccination the patient also developed cough,headache,myalgia,fever,fatigue. The patient experienced the following serious criteria: Medically Significant. The eventual diagnosis made on was Syncope .  The Physician did not declare any relatedness between fainting and Moderna COVID-19 Vaccine.  The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons  (probably due to pre existing disease); there is no plausible mechanism to implicate the drug.  .   Terse Narrative (for narratives and signal review) Brief 3 line summary of above for Regulatory Authority listing: Report Source- Physician,  Age- 52 Years,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome- fatigue - Recovered/Resolved,fainting - Recovered/Resolved,fever - Recovered/Resolved,myalgias - Recovered/Resolved,headache - Recovered/Resolved,cough - Recovered/Resolved.; Reporter's Comments: Patient ID:     Investigator Site:   Case reference number MOD-2021-013971 is a clinical trial case report which refers to a 52 Years old Female patient.  The patient experienced fainting which resulted in medically significant .    .  The patients started Moderna COVID-19 Vaccine on  .  Some  2 days  later, the patient developed fainting.'  Relevant laboratory results included   and relevant physical signs were <LIST PHYSICAL SYMPTOMS>. The patient experienced the following serious criteria: -Medically Significant  The eventual diagnosis made was Syncope .The event(s) were:  fatigue - Recovered/Resolved,fainting - Recovered/Resolved,fever - Recovered/Resolved,myalgias - Recovered/Resolved,headache - Recovered/Resolved,cough - Recovered/Resolved.  Based on 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.
pt recv vax 19APR96 & 18AUG96 pt devel a vesicular lesion on rt hand;lesions spread up the entire rt arm to the deltoid area w/approx 50 lesions; pt dx w/shingles;PCR analysis of a specimen from pt revealed the Oka/Merck varicella vir
Flu like symptoms with aches and chills.  Mouth broke out (roof of mouth) with a rash, tender.  Also rash on left breast and both buttocks.  Throat became irritated and scratchy.  Stroke like effects to both eyes with rainbow effect for 45 minutes.
Admitted 9/25 for SOB, sx onset 9/15 Reports fever, body aches, cough; home sats readings 88-89% for 3 days prior to admission  67 Y male with a h/o smoking ( 10 pack years, quit last year), metastatic rectal cancer, claustrophobia, h/o post-polio syndrome admitted for acute hypoxemic respiratory failure 2/2 to COVID-19 PNA.  Pt. being treated in the hospital x5 days w/ remdesivir and decadron x10days
patient came in for a Moderna COVID vaccine and was supposed to receive her first primary dose of COVID vaccine Moderna but there was miscommunication on which dose it was supposed to be. It was confirmed that patient was going to receive the Bivalent booster and was given the bivalent. However, after the administration, the patient then confirmed that it was her first dose ever for a COVID vaccine. patient waited and was observed for 15 minutes and there was no adverse side effect. Everything was reported when it occurred.
I know 6 people that got the shot and then got shingles /Suspected vaccination failure; I know 6 people that got the shot and then got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows; The age at vaccination was not reported. The reporter stated that, the patient got the shot and then got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided. This case was 1 of 6 linked cases reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR161278:Same reporter. Pt 2/6 US-GLAXOSMITHKLINE-US2021AMR161279:Same reporter. Pt. 3/6 US-GLAXOSMITHKLINE-US2021AMR161280:Same reporter. Pt 4/6 US-GLAXOSMITHKLINE-US2021AMR161281:Same reporter. Pt 5/6 US-GLAXOSMITHKLINE-US2021AMR161282:Same reporter. Pt 6/6
Information has been received from a registered nurse, via a company representative, concerning a female patient who was vaccinated with the first dose, IM, of Gardasil (date not specified). Subsequently the patient broke out into a rash on her neck and abdomen. The nurse stated that the patient was advised to take Benadryl as treatment. At the time of the report, it was unknown if the patient had recovered from the rash though the patient was scheduled to be seen in the office on 29-MAR-2007. Additional information has been requested.
Patient with history of dementia. He was brought in by EMS to the ED from his living facility on 12/23/22 for worsened mental status and multiple recent falls. He additionally was reported to have tested positive for COVID the day prior (12/22/22). Additional COVID PCR test performed in the ED was also positive. Ultimately, patient was admitted 12/23/22. Diagnoses include multifocal pneumonia secondary to COVID-19, aspiration pneumonia, and demand ischemia, among other diagnoses. He was planned for discharge back to his living facility 12/26/22, however returned to the hospital as the living facility said they did not have the staff for him. On 12/27, his family requested hospice and the patient was transitioned to comfort cares. He passed away 12/30/22.
Fever, Headache, Pain at injection site, Fatigue, Muscle pain, Chills, Joint pain, Injection site swelling and redness, Malaise, Lymphadenopathy
Expired TENIVAC was administered to the patient/No AE; Initial information was received on 13-Aug-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 59 years old female patient who was administered with 0.5 mL once dose of expired vaccine  DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (Injection, lot U6021AA and expiry date 27-Jul-2020) via intramuscular route in the arm for prophylactic vaccination on 12-Aug-2020 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. No other concomitant vaccines were given.  It was an actual medication error case due to expired vaccine used (latency on same day).  At a 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.
This spontaneous report as received from a medical assistant refers to a 12 month old patient of unknown gender. On 15-DEC-2014, the patient was inadvertently vaccinated with an expired dose of VAQTA lot # 0672AE, expiration date reported as 07-DEC-2014, one dose (reported as 1 dose), 0.5 ml dose, intramuscular (dose number was not reported). No adverse effects were reported. No product quality complaint (PQC) involved. Additional information has been requested.
Got the shot on Friday, had normal symptoms on Saturday, felt great on Sunday. Monday I got sick and I?ve been sick ever since. I?m coughing so hard that I tore my throat. I?ve had extreme flu symptoms for a week. My fever never surpasses 99.1 but I have mucus, sneezing, severe fatigue, severe cough. I?ve had to take off work, quarantine because think I have covid. It?s terrible and no one else I?ve talked to has had it this bad.
I started having gastrointestinal pain and was unable to go the bathroom to eliminate fecal waste. On September 26, 22 I had reached out to my GI doctor about my issue. He started me on LINZESS. I called my doctor and had a telehealth visit on October 24, 22 as I was unable drive. We discussed my symptoms; she did not give me any medications or change any medications at this time. On December 6, 2022, I went to a local emergency room I was having GI pain with other pain in other parts of my body. I had a CT scan that revealed I had esophagitis. On December 14, 2022, I had an endoscopy that showed I had Duodenitis. I was given NEXIUM to help with calm this issue. It did help for a while then I started getting stringy filaments all over my body. My PCP referred me to a have a throat culture done on February 22, 2023. I just received the results that showed that I have Candida Dubliniensis. I am awaiting to get with my doctor to go over the results.
Initial unsolicited report received from a pharmacist on 11-Oct- 2016. This case involves a 76-year-old female patient who was vaccinated with a dose of Fluzone HD via intramuscular route (lot number: UI664AA, expiration date: 06-Apr-2017; dose not reported) in right deltoid on 11-Oct-2016. Reporter denied illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions. On 11-Oct-2016, same day after vaccination, the patient experienced a bump at the injection site. Lab data and corrective treatment were not reported. The outcome of the events was reported as unknown. List of the documents held by sender: none.
The pt experienced hives on stomach and back with an onset of one day post vax. No swelling, no respiratory symptoms. Hive most noticeable on 11/1 but itching began on 10/31.
pt devel a rash over chest & back which was raised & red 10 days p/vax;rash spread over the next 2 days when saw;had greater than 100 papulovesicular lesions over trunk, face & extremities;dx varicella made;