chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Guillain-Barre syndrome/spinal test that was positive for Guillan-Barre syndrome; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome/spinal test that was positive for Guillan-Barre syndrome) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome/spinal test that was positive for Guillan-Barre syndrome) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome/spinal test that was positive for Guillan-Barre syndrome) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Spinal X-ray: positive (Positive) positive for Guillain-Barre syndrome.         No concomitant medications information was reported. No treatment medications were provided.  Company Comment: This report refers to a case of  Guillan-Barre syndrome in a 60-year old female which developed after vaccinating with second dose of mRNA-1273. 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.; Sender's Comments: This report refers to a case of  Guillan-Barre syndrome in a 60-year old female which developed after vaccinating with second dose of mRNA-1273. 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.
pt had DTP 19MAY92 mom called 25JUN92 w/ c/o RAT is hard & has a knot & is bruised; also has chicken pox & a red streak on rt leg; doesn't know if red streak related to DTP or chicken pox;
Diagnosed with immune thrombocytopenia (ITP) 4 weeks following second GARDASIL dose. Platelet count was 3000 at the time of diagnosis. ITP is now considered chronic. Treatments have included WinRho, IVIG, prednisone and rituximab. Patient is still under treatment.
This spontaneous report was received from a licensed practical nurse, referring to a 11 year old, female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 21-JUL-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the left arm (reported as LD), lot # K026247 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
GI bleed, acute on crhonic resp failure, COVID +; sepsis, decadron, zinc, Vit K given for INR 7.5; TOBI given, no COVID symptoms other than increased O2 requirements. PT on 6L O2. remdisivir given. O2 weaned to 1.5 L. Sputum +for pseudomonus, IV cefepime for 14 days. home with IV abx
Pain, numbness to arm after GARDASIL shot.  Numbness spread to arm and lasted about 2 wks.
Medical Assistant forgot to mix the ActHIB and the Ipol and the DTAP and only injected the Ipol and DTAP/ No AE; Initial information received on 26-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old male patient for whom it was reported that Medical Assistant forgot to mix the ActHIB and the Ipol and the DTAP and only injected the Ipol and DTAP (Inappropriate reconstitution technique) while received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] 0.5 mL dose, lot C5426AA via intramuscular route in the left thigh on 26-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  It was a case of actual medication error due to inappropriate reconstitution technique.  The patient did not have any AE as a result of this event.  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.  Documents held by sender: none.
Patient is fully vaccinate.  COVID positive on admission 5/13/2022.   66y.o. female w/ a PMHx of cerebral palsy, GERD, asthma, anxiety and depression who presents to the  ED d/t sudden difficulty in breathing and trouble swallowing. Patient's mother states that patient has been diagnosed with COVID-19 since May 4.  Her initial symptoms were cough, sore throat and body aches.  She then presented to her family physician who prescribed her Paxilovid, after few initial doses patient started develop diarrhea and then paxlovid was discontinued.  Mother reports overall improvement of COVID since taking Paxlovid.In the ED,  pt was patient presented for episode of shortness of breath secondary aspiration of food.  CXR: no acute process. not hypoxic, decadron not indication.  Monitor for signs of aspiration pneumonia.  Discharged home.
Itchy raised red rash that spread to 8 inches in diameter on right arm, injection site. Headache, body aches, fatigue.
Myalgia, Arthralgia, chills, left arm soreness at injection site Narrative:
See letter-vaccination given in wrong anatomical location- See letter - Synovitis/Bursitis. Rt shoulder - (follow up pending). I recently went to a Pharmacy for a PREVNAR 13 vaccination. When I returned home I noticed the vaccine bandage was over the point of my shoulder-not in the widest area of the Deltoid muscle. I am concerned about shoulder injury from a synovitis with an immune mediated inflammatory response. See JAPA paper send and pictures of where needle was placed in my shoulder. It is 48 hours after the injection and the shoulder is still very painful. I would appreciate your response and recommendations.
I have been in menopause for more than 4 years. I had a period the day after I took the 3rd dose. I experienced cramps as well. I thought it was very bizarre. I saw my gynecologist. I am also scheduled for an ultrasound. I am currently experiencing some cramping.
Received MMR/VARIVAX/Hep A on 9-17-13. Began with rash on torso plus temp of 101 degrees on 9-25-13, vomited x 2 that day but none since then. Alert but fussy. Appetite decreased. No c/o diarrhea.
Pediatric vaccine was diluted with 0.13 ml instead of 1.3 ml so the patient got a more concentrated dosage than recommended.  Patient  experienced  severe pain at injection site and fever that lasted 48 hours but has since got better.
Pt ran fever & screamed in pain most of day inject given; Next morning had fine red rash on chest & back x/solid red area size of the palm of hand under the left breast; Next day rash worse covering neck, chest & shoulders;
Severe menstrual bleeding to almost needing transfusion. Eventual hysterectomy.
pt recv vax & 8AUG98 & 9AUG98 T100 & just didn't feel well;soreness @ inj site lt deltoid & swelling size half dollar;
received only the diluent component; received only the diluent component; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th August 2021, the patient received Shingrix. On 25th August 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received only diluent component of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
feeling of a swollen tongue, tingling in face, numbness feeling in face and tongue. Persisting for three weeks after first dose intermittently.
Narrative: COVID infection following COVID vaccine series 01/26, Pfizer, dose #1 02/12, Pfizer, dose #2 12/29 COVID swab, result: detected 12/29 pt cc: productive cough, yellow phlegm, chest tightness and malaise exposure: unknown 12/26 pt admit to ED cc: productive cough, yellow phlegm, chest tightness and malaise dx: cute Viral Syndrome, COVID-19 12/29 CXR impression: No acute cardiopulmonary process. 12/29 PROCALCITONIN: <0.05 12/29 ESR: 56 12/29 DDIMER: 0.46
PATIENT IN A NURSING FACILITY AND CHECKLIST QUESTIONS ANSWERED SAID THE PATIENT HAD NOT RECEIVED A DOSE OF COVID-19 VACCINE.  UPON ENTERING INFORMATION IN SYSTEM, PHARMACY HAD RECORDED THAT THE PATIENT RECEIVED PFIZER ON 1/25/2021.  UPON FURTHER QUESTIONING OF MULTIPLE STAFF MEMBERS AND CONSULTING PATIENT'S CHART, THERE IS NO RECORD AT THE FACILITY OF SUCH, BUT PHARMACY DOES HAVE A RECORD THAT IT WAS ADMINISTERED.  PATIENT HAD NO ADVERSE EVENT TO VACCINE ON 6/8/2021
Nausea; She was very limp, she was throwing up and very dizzy; She was very limp, she was throwing up and very dizzy; She was very limp, she was throwing up and very dizzy; Severe Headache; Light sensitivity; This is a spontaneous report from a contactable consumer (patient's mother). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration on 10Jun2021 (at the age of 16-year-old) as single dose for Covid-19 immunization at a Hospital. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The reporter stated that patient was very limp, she was throwing up and very dizzy and with a very severe headache and light sensitivity. Patient never had any of those type symptoms before and happened four days after she got the COVID shot. Reporter stated that, the evening of the 13Jun2021. It was headache and the headache got very severe through the next day. Reporter stated that, she had no idea and do not think it was anaphylactic reactions. She thought it was a severe headache which been reported and the MRI they were looking for blood clot as patient was experiencing severe headache that need her throw up, she did not know 100 times, and that end up in the hospital. There was light sensitivity when the CT scan and lumbar puncture was done to see if there was meningitis. CT-scan and spinal patch were done and patient was given nausea and dizzy medications and reporter and patient were waiting for the MRI. The events were serious (hospitalization) on 16Jun2021. The patient underwent lab tests and procedures which included computerised tomogram: unknown and lumbar puncture: unknown on an unspecified date in Jun2021. Therapeutic measures were taken as a result of events dizzy and nausea. Outcome of the events was unknown.  Information about lot batch number has been requested.
Fever of 102 Chills Headache Body aches Lower back pain Left ovarian pain Itchy bumps on palm of hand Extreme fatigue  Lethargy  Sleeping all day for 3 days
pt recv vax & had nasal congestion & sneeze;blood filled clot appeared in mouth;20SEP98 E. Multiforme on thighs & abd;21SEP98 diffuse petechia & fever;many areas mucosal bleeding;ITP;
Patient is a 79 y.o. male who presents with  on 9/14 to an outlying facility with complaints of generalized body aches, nausea, loss of appetite, progressive dyspnea, cough dry nonproductive.  Symptom onset was 9/9/2021, date of positive test is 9/14/2021.  Fully vaccinated in March.  He was started on COVID supplement, IV Decadron, baricitinib and remdesivir with minimal improvement of respiratory status.  His oxygen requirement increased and he was placed on BiPAP.  He developed new onset A. fib with RVR, started on Cardizem drip.  He was transferred to a higher level of care on 9/19/2021.
Patient noticed swelling of his right supraclavicular lymph nodes beginning 2 days after vaccine administration. Patient admits to mild tenderness of the lymph nodes. Denies any other symptoms. Admits to performing yard work over the weekend.
Second episode of symptoms included altered concentration level, spasticity of head/neck, neck pain, difficulty swallowing, difficulty speaking - "spasticity dysphonia", tremor, stiffness, muscle spasms, laryngospasm, pneumonia, cyanosis, truncal instability, opisthotonus, reflex spasm, muscle twitching, episodic jerking/myoclonus, hyperreflex, ataxia, freezing, shuffling, falls, etc. Symptoms would wax and wane. Treatment included penicillin, prednisone, ROBAXIN, clonazepam, primidone, potassium chloride, vitamin D supplement, antihistamine, various headache medications, speech therapy, etc.
herpes zoster; This initial spontaneous report was received from a lawyer an adult patient of unknown gender regarding a case in litigation. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 28-MAR-2011, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, route and lot # were not provided) at a medical center for the long-term prevention of shingles and zoster-related conditions.  Subsequently, on an unknown date, the patient was treated by a provider for the following injuries resulting from zoster vaccine live (ZOSTAVAX): herpes zoster. At the time of the report, the patient's outcome was unknown.   The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Lethargy and fever 99.7 'F from oral thermometer, started 24 hours after dizziness progressed. Slight trouble breathing and discomfort.
body pain and body aches; Chills; Fever slightly over 100 degrees F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body pain and body aches), CHILLS (Chills) and PYREXIA (Fever slightly over 100 degrees F) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced PAIN (body pain and body aches), CHILLS (Chills) and PYREXIA (Fever slightly over 100 degrees F). At the time of the report, PAIN (body pain and body aches), CHILLS (Chills) and PYREXIA (Fever slightly over 100 degrees F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Pyrexia: 100 100 degrees F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
big rash (rash around the injection site); soreness where she received the vaccination on her right shoulder; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH and VACCINATION SITE PAIN (soreness where she received the vaccination on her right shoulder) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced INJECTION SITE RASH (rash around the injection site) and VACCINATION SITE PAIN (soreness where she received the vaccination on her right shoulder). The patient was treated with Manual therapy of applied alcohol for Injection site rash. On 10-Apr-2021, INJECTION SITE RASH (rash around the injection site) and VACCINATION SITE PAIN (soreness where she received the vaccination on her right shoulder) had resolved. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment medications were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above included, On 06-Jul-2021: No significant information was received.
pt recvd vax; pt devel hives; pt seen in ER & tx w/ unspecified inject & prescription medication;
I was giving the injection, it leaked onto my hand, no AE; pharmacist was giving a patient a Fluzone High Dose and almost half of the dose came off on my shot and shirt, no AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  The case is linked with 2019SA268222 (same reporter).  This case involves a 65 years old male patient who received almost half of the dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ236AA, expiry date: 04-Apr-2019, via intramuscular route in the right arm) and half of the dose was came off on my shot and shirt on 19-Sep-2019  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of vaccine underdose and syringe issue.  At the time of reporting the patient had no adverse event.  It was also reported that screwing the needle on tight for injecting the dose her gloved hand was suddenly wet from the vaccine leaking. She stated the leaking must have come from the barrel of the syringe on the side or perhaps the orange part of the needle because that is where her finger was resting. Rph mentioned the other doses in the carton were fine to administer. She asked if the dose should be repeated, she will call the patient back to the pharmacy.  Needle type: Safety, BD safety glide, 25g by 1 inch.  List of document held by sender: none.
Started to feel little light headed they gave me ice water about 12 minutes after shot, at 30 went to car .when took off mask my cheeks where fire engine red and quite swollen, mouth was feeling tingly, went back to facility, nurse said to take my Benadryl and if gets worse call doctor,.  My face stayed swollen and sides of neck got red and pills felt stuck deep in back of my throat. Started taking Zyrtec,Allegra,Benadryl in a rotation every 2-3 hours in between, could take up to 4 doses of each anti histime in a day. nurse practitioner 4/2 11:30am, she added 2 doses of Pe I?d to the rotation. I continue to have  face/mouth swelling intermittently and pills still feel stuck in my throat. Arm swelled day for at injection site with a sand dollar size red rash:pain ful. On 4/2-4/4 had horrible headache..
Patient was a well and active 92 year old man, who walked 2 miles daily with a walker.  He received Covid vaccine dose 1 on 11 Jan.  On or before 30 Jan, he noted pains in one leg while walking.  Newly dilated veins on the lower leg were noted. On feb 2 a doppler US revealed a superficial saphenous vein venous thrombosis, also new onset A flutter. Aspirin begun. On Feb 5 he woke with a cold foot (same side) and was found to have an arterial thrombus from SFA through distal posterial tibial.  He underwent emergency thrombectomy, went to rehab for recovery, on Feb 23 suffered intracranial hemorrhage and died on Mar 10.
This spontaneous report was received from a nurse practitioner regarding a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX subcutaneous injection, per intramuscular route in error, for prophylaxis (strength, dose, frequency, anatomical location, lot # and expiry date were not provided). No known adverse effects were reported.
sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J2014) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Dec-2020, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at a dose of 600 mg. On 25-Dec-2020, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported.    This case was linked to MOD-2021-013927 (Patient Link).; Sender'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.
Axilla is still swelling for a long time; This spontaneous case was reported by an other health care professional and describes the occurrence of AXILLARY MASS (Axilla is still swelling for a long time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AXILLARY MASS (Axilla is still swelling for a long time). At the time of the report, AXILLARY MASS (Axilla is still swelling for a long time) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment medications were not provided.