chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; Still got the Shingles; Nerve pain; itching; Discomfort of Shingles; eased the pain; they about drove me nuts; This case was reported by a consumer via interactive digital media and described the occurrence of 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), shingles, post herpetic neuralgia, pruritus, discomfort, pain and feeling abnormal. On an unknown date, the outcome of the vaccination failure, post herpetic neuralgia, pruritus, discomfort and feeling abnormal were unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the pain was recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia, pruritus, discomfort, pain and feeling abnormal to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's comment: This case was reported by a patient via   interactive digital media. The patient received the Shingles vaccine but still got the Shingle and they were a milder case. But the patient was just thankful that it was not any worse. Shingles had about drove patient's nuts. The patient experienced nerve pain and itching.  The patient had heard that pomifera healing oil would help with the discomfort of Shingles so patient ordered some and was amazed at how it helped.  The patient would rubbed it on shingles and it eased the pain.  The patient had recommended it to several and they said it worked for them. Follow-up would not possible, as no contact details were available. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
UNUSUAL FEELING IN SKIN, ALL OVER BODY AND HEAD; FEELING LIKE CRAWLING; ITCH ALL OVER; FEELING LIKE TINGLING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On AUG-2021, the patient experienced unusual feeling in skin, all over body and head. On AUG-2021, the patient experienced feeling like crawling. On AUG-2021, the patient experienced itch all over. On AUG-2021, the patient experienced feeling like tingling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unusual feeling in skin, all over body and head, feeling like tingling, feeling like crawling, and itch all over. This report was non-serious.
Patient is a 50 yo F with PMH of prior allergies including to sulfa drugs and yellow dye, with prior history of anaphylaxis. Patient here today for 1st dose of COVID-19 vaccine. Received dose 1 of Moderna COVID-19 vaccine at around 8:25a. Approximately 5 minutes later, patient reported eyes closing and difficulty breathing.    On exam, patient with moderate respiratory distress, some difficulty speaking, eyes swollen, tachycardia, wheezing bilaterally. Initial vitals hypertensive, O2 >98%, HR 110s.    1st dose of epinephrine 0.3 mg given IM to L thigh about 8:32a with immediate improvement in symptoms. EMS called and arrived shortly afterward.  Patient also took 25 mg diphenhydramine chewable tablets.    Patient with recurrent symptoms of difficulty breathing in preceding several minutes.   2nd dose of epinephrine 0.3 mg given IM to L thigh about 8:38a with interval improvement of symptoms.    Patient maintained adequate oxygenation with O2 > 98%, BP remained hypertensive and HR tachycardic >110.    Patient left by ambulance to Medical Center.
Serious UTI, chills, low fever, lower abdomen pain/bloating. Constant need to urinate.   Started Wednesday evening, by  Thursday afternoon needed to lay down.  By Thursday evening seriously hurting and chills.  All accompanied by a headache.  Friday went to doctor, urine sample confirmed bacterial UTI, also my white blood count was extremely high. Received shot in hip of antibiotics, and Rx for Ciptro.  Follow up one week later (started to feel better on Monday (3 days later).  Doctor will retest my blood after I complete antibiotics.
CTA of the chest from 28Dec2022 suggested pericarditis; Pt developed shortness of breath; chest pressure; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "CLL" (unspecified if ongoing); "gout" (unspecified if ongoing). Concomitant medication(s) included: VENETOCLAX; OBINUTUZUMAB; QUETIAPINE; VENLAFAXINE; ULORIC; WELLBUTRIN; VITAMIN D3. Past drug history included: Allopurinol, reaction(s): "Known allergy: allopurinol". Vaccination history included: Covid-19 vaccine (Dose 3 (Booster), Unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 1, Unknown manufacturer), for Covid-19 Immunization. Patient had no COVID prior vaccination and had not tested post vaccination. The following information was reported: PERICARDITIS (medically significant) with onset Dec2022, outcome "recovered", described as "CTA of the chest from 28Dec2022 suggested pericarditis"; DYSPNOEA (medically significant) with onset Dec2022, outcome "recovered", described as "Pt developed shortness of breath"; CHEST DISCOMFORT (medically significant) with onset Dec2022, outcome "recovered", described as "chest pressure". The events "cta of the chest from 28dec2022 suggested pericarditis", "pt developed shortness of breath" and "chest pressure" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Angiogram: (28Dec2022) pericarditis; Echocardiogram: (05Jan2023) negative, notes: performed after symptoms had resolved. Therapeutic measures were not taken as a result of pericarditis, dyspnoea, chest discomfort. Clinical course: Patient developed shortness of breath with chest pressure. CTA of the chest from 28Dec2022 suggested pericarditis. Echo performed on 05Jan2023 after symptoms had resolved was negative.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and possible temporal association, the contributory role of BNT162b2, BNT162b2 omi ba.4-5 to the reported Pericarditis, Dyspnoea and Chest discomfort cannot be completely excluded. Case will be further reviewed upon receipt of FU information.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Fever & irritability developing the evening following vax; Brief-sz-like activity (tonic-clonic) & fixed gaze, followed by period of sleep;
THIS LOCATION WAS INSTRUCTED TO PICK UP PFIZER VACCINE FROM HUB STORE FOR USE 3/24/21 AND 3/25/21.  THERE WAS NO EXPIRATION DATE OR SIMILIAR INFO ON THE PACKAGING IN WHICH WE RECEIVED THE VACCINE AND DILUENT.  SINCE WE WERE TOLD TO USE THE VACCINE ON THESE DAYS ONLY (WE NORMALLY USE MODERNA). THE ASSUMPTION WAS THAT THE VACCINE WOULD BE WITHIN ITS BUD/TIME.  OUR STORE MANAGER WAS INFORMED AT END-OF-DAY ON 3/25/21 THAT VACCINE HAD EXPIRED AT 11:00 AM THAT DAY.  CONSULTATION WITH PFIZER INDICATED THAT THE DOSE DID NOT HAVE TO BE PREPARED FOR PATIENT.
Initial report was received 04 June 2009 from a health care professional as part of a cluster. A 24-year-old female patient, had received a left deltoid injection (route not reported) of ADACEL, lot number UF455CA (corresponding Sanofi Pasteur Ltd, lot number C3004) at 3 PM on 13 January 2009, and the following morning, on 14 January 2009, she developed chills and muscle and joint pain which had been worse in her legs and buttocks. At 5 PM that same day she developed a fever of 101 degrees Fahrenheit and subsequently had a restless night sleep. By the following evening on 15 January 2009, the symptoms had resolved and the patient recovered. The events did not require a doctor's visit. This patient is one of a cluster of five identified patients, out of a possible 6 or 7 patients. The other four identified patients have been captured in case numbers 2009-00586, 2009-02398, 2009-02400, and 2009-0401. This case also has the same reporter as case number 2009-00128.
Pt reports she had trouble by the afternoon after the vaccine. Pt could not lift her arm (left). 2-3 weeks later she was diagnosed with tendonitis by her physician. She received a cortisone shot. Still has pain and does not have full ROM.
Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.
Frequent heart flutters/palpitations noted within two days after vaccine, but patient did not initially consider any connection to vaccine.    At a routine physical on 12/21/22, noted issue to doctor, who performed an in-office EKG which showed normal heart activity.    Physician  advised that heart flutters are a symptom of COVID19 but also may be a symptom of the vaccine.  Heart flutters/palpitations have lessened over time and are much less frequent as of this writing, 2.5 weeks later.
Adult given a pediatric Hep B and left clinic. Client made aware and will give adult dose when client returns per ACIP guidelines.
Numbness in both feet, bilateral paresthesia in feet; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in both feet, bilateral paresthesia in feet) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M2A and 039K20-2A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Hypercholesterolemia, GERD, BPH and Erectile dysfunction. Concomitant products included TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN [TAMSULOSIN HYDROCHLORIDE]) for BPH, TADALAFIL for Erectile dysfunction, OMEPRAZOLE for GERD, BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) for Hypertension, FLUTICASONE PROPIONATE for Sinus congestion, ATORVASTATIN and COLECALCIFEROL (VITAMIN D3) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced HYPOAESTHESIA (Numbness in both feet, bilateral paresthesia in feet). At the time of the report, HYPOAESTHESIA (Numbness in both feet, bilateral paresthesia in feet) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After the first vaccine in January, then five weeks later, the patient had numbness in both feet. Patient had underwent several lab tests- X-rays, bloodwork and all sorts of test run and still was not able to explain why the both feet were numb. The both feet were numb and he had an electromyograph done, very symetric, the numbness developed after the second vaccine, this was a fast gradual onset. No treatment information was provided. Medical history also include unspecified prostate.  Lab test done:  EMG- June 14 2021 Heavy Metal Scan- May 19,2021 HGB A1C- May 19,2021 Immunofixation Screen- May 19 2021 Vitamin B12- April 2021 TSH BLD- April 15 2021 T4 Free/ Free Thyrox- April 15 2021 T# BLD- April 2021 XR Sacrum/Coccyx 3V AP/LAT- April 15 2021 XR Lumbar General 3V AP/LAT/L5-S1- April 15 2021   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Patient details, Medical history, Concomitant medication, Event start date and Outcome updated.
Chills; fever; body ache; loss of taste; headache; 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), administered in arm left, administration date 18Mar2022 16:00 (Batch/Lot number: unknown) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma; "high blood pressure" (unspecified if ongoing), notes: other medical history: high blood pressure. Concomitant medication(s) included: TRELEGY; SINGULAIR; LISINOPRIL; APPLE CIDER. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 03Sep2021, when the patient was 26 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Vaccine Administration Time: 05:00 PM), administration date: 13Aug2021, when the patient was 26 years old, for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 19Mar2022 12:00, outcome "not recovered", described as "Chills"; PYREXIA (non-serious) with onset 19Mar2022 12:00, outcome "not recovered", described as "fever"; PAIN (non-serious) with onset 19Mar2022 12:00, outcome "not recovered", described as "body ache"; AGEUSIA (non-serious) with onset 19Mar2022 12:00, outcome "not recovered", described as "loss of taste"; HEADACHE (non-serious) with onset 19Mar2022 12:00, outcome "not recovered", described as "headache". Therapeutic measures were not taken as a result of chills, pyrexia, pain, ageusia, headache.  Additional information: patient did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient not had been tested for COVID-19. Patient had known allergies.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Severe Headache; extremely scratchy eyes, Fever; Fatigue; Site pain; Body aches; Slightly disorientated, for about 24-48 hours
Fever,  vomiting, chills. achy body, headache, tingly L hand
Patient received Gardasil vaccine on 7/16/2008 and subsequently was noted to have jerking movements; patient also complained of tingling and pain with her extremities.  Patient was subsequently hospitalized where she was evaluated and monitored. 8/21/08-ED records received for DOS 7/22/08-Presented with C/O burning sensation in chest, headache and feeling funny. facial swelling and hand swelling began yesterday. Pain in both legs with headache. Movement disorder twitching movements. Neuro consult observed episodes of shoulder shrugging. Impression: conversion disorder.
Brain Fog Insomnia some nights Fuzzy Vibrational Tingling Feeling all over my body Legs hurt Feels like my cells are being attacked Feels like my muscles are being ate away Unable to concentrate  Nerve twitches
Severly cold for two days.  Body pains.  Pain in my upper inner thigh making it difficult to walk.
Fever with lethargy approx. 8 hours after vaccination. Reported following day by mother. Denies any other symptoms other than slight "runny nose", temp 102 degrees, treated with Tylenol and Ibuprofen. Improved approx. 36 hours.
This spontaneous report was received from a nurse via a company representative and refers to a female patient of unknown age (the reporting immunization nurse). There was no information about the patient's concurrent conditions and concomitant therapies provided. The patient's medical history included shingles that had occurred on unspecified dates prior getting vaccination with ZOSTAVAX. On an unknown date in November 2017, reported as about 2 weeks ago, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml (one dose) (route of administration, lot# and expiry date were not reported) for shingles prevention On an unknown date in November 2017, the patient developed some redness and itchiness around the injection site on her right arm. The nurse reported that she had these symptoms persist for approximately one week and a half before she recovered from the adverse events. The patient did not sought medical attention. The outcome of injection site erythema and injection site pruritus was reported as recovered on an unknown date in November 2017. The relatedness between the events and ZOSTAVAX was not reported.
On March 13, 2023, had cold symptoms, had strep throat. I was given Amoxicillin. On 04-11-2023, developed chills, fatigue, body aches and a headache. I did not go to an urgent care. I took Advil for the body aches. I have recovered from my symptoms today.
This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a female patient who received Shingles vaccine for prophylaxis. On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved. It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient received the shingles vaccine and felt ill for 8 hrs.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Dec2021 at 12:00 as dose 1, single (Lot number: Fh8028) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: seafood" (unspecified if ongoing), notes: Known allergies: seafood. Concomitant medication(s) included: VERAPAMIL. Past drug history included: Sulfur, reaction(s): "known allergy: Sulfur", notes: Known allergies: Sulfur. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: Repeated antigen test and it positive; (07May2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid: start date: 02May2022, stop date: 6May2022, Indication: Treatment of COVID-19. The patient taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine. Device Date : 11May2022.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning a 13 year old female patient who was vaccinated with the first, second and third dose of GARDASIL separately on 17-NOV-2008, 04-FEB-2009 and 04-JUN-2009. The physician did not know the patient was pregnant until an appointment in July 2009. The patient had done urinary test to confirm pregnancy. It was found out at this time the patient was pregnant for 5 months. The patient's date of last menstrual period was approximately on 01-FEB-2009 and estimated delivery date is 08-NOV-2009. Follow up information has been received indicating the patient had an elective abortion in August 2009. Upon internal review, the patient's elective abortion was considered an other important medical event. Additional information has been requested.
Left arm, not where needle went in, but back of arm developed from shoulder to elbow, became extremely red, hot and painful could not raise arm. 3 Drs looked at it 11/16/2005 am were in awe. Treatment suggested Prednisone 20 mg 10 tab 1 per day. Clarinex 5mg 50 at 1 per day. Drs office had me come back for ck up 11/16 to 11/20 finally went away.
Third dose or booster shot: Just kind of out of it; Third dose or booster shot: trouble swallowing, difficulty swallowing; Third dose or booster shot: Began salivating quite a bit; Third dose or booster shot: Became more somnolent; Third dose or booster shot: Just kind of out of it; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). A 64-year-old female patient received bnt162b2 (BNT162B2), administration date 06Dec2021 13:30 (Batch/Lot number: unknown) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (ongoing), notes: Onset probably since she was a child of 7 or 8 years, but just undiagnosed at that point. She is paraplegic so he has to help her get in bed himself because she can't stand.; "High blood pressure" (ongoing), notes: Onset date unknown other than several decades back. Concomitant medication(s) included: AMLODIPINE taken for hypertension (ongoing).Vaccination history included: Bnt162b2 (First dose: Date administered: Unknown, months ago he guessed. Lot/NDC/Expiry: Unknown, caller did not have CDC vaccine record card with them at time of the call.), for COVID-19 Immunization; Bnt162b2 (Second dose: Date administered: Unknown, months ago he guessed. Lot/NDC/Expiry: Unknown, caller did not have CDC vaccine record card with them at time of the call.), for COVID-19 immunization.The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021, outcome "unknown", DYSPHAGIA (non-serious) with onset 06Dec2021, outcome "recovered" (06Dec2021) and all described as "Third dose or booster shot: trouble swallowing, difficulty swallowing"; SALIVARY HYPERSECRETION (non-serious) with onset 06Dec2021, outcome "recovered" (06Dec2021), described as "Third dose or booster shot: Began salivating quite a bit"; SOMNOLENCE (non-serious) with onset 06Dec2021, outcome "recovered" (06Dec2021), described as "Third dose or booster shot: Became more somnolent"; FEELING ABNORMAL (non-serious) with onset 06Dec2021, outcome "recovered" (06Dec2021), described as "Third dose or booster shot: Just kind of out of it".The lot number for bnt162b2 was not provided and will be requested during follow up.
Pinpoint, itchy, hot rash starting on chest, progressing to neck and face over 7 days.