chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Intermittent: facial twitching, eyes twitching, 2 fingers of right hand involuntarily moving and twitching, nerves jumping in legs; Intermittent: 2 fingers of right hand involuntarily moving and twitching; Intermittent: toes twitching and spasms; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 74-year-old non pregnant female patient received bnt162b2 (BNT162B2 formulation; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 06Feb2021 (Batch/Lot Number: EM9809) as DOSE 1, SINGLE (at the age of 74-year-old) for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included SVT (supraventricular tachycardia), A-Fib (atrial fibrillation), Hashimotos disease, Fuchs corneal dystrophy, asthma and Known allergies to shellfish from an unknown date and unknown if ongoing. The patient not diagnosed with COVID prior to vaccination. Concomitant medications included montelukast sodium (SINGULAIR), apixaban (ELIQUIS), d-mannose (D-MANNOSE) and fish oil (FISH OIL) all concomitant's taken for an unspecified indication, start and stop date were not reported. The patient previously took bactrim and experienced Known allergies. The patient did not receive any other vaccine in four weeks. The patient had Intermittent: facial twitching, eyes twitching ,2 fingers of right hand involuntarily moving and twitching, toes twitching and spasms, nerves jumping in legs on 08Feb2021. The patient not tested for COVID post vaccination. No treatment received for events. The outcome of events reported as not recovered.   Follow-up attempts completed. No further information expected.
Felt aches for a day; Initial information was received on 18-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender of patient who reported that felt aches for a day after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Covid-19 Vaccine.  On an unknown date, the patient received a dose of suspect influenza vaccine (produced by unknown manufacturer) (formulation, strength, dosage, expiry date, lot number not reported) via unknown route in unknown administration site in prophylactic vaccination(Immunization).  On an unknown date the patient developed non-serious event of felt aches for a day (pain) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (Felt aches for a day).  At time of reporting, the outcome was Unknown for the event felt aches for a day.
Patient received second dose of the Moderna COVID-19 vaccine 19 days after the first dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose of the Moderna COVID-19 vaccine 19 days after the first dose.) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0400C21A and 040C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose of the Moderna COVID-19 vaccine 19 days after the first dose.). On 28-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose of the Moderna COVID-19 vaccine 19 days after the first dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported. No lab data was provided by the reporter
numb lips; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA ORAL (non-serious), outcome "unknown", described as "numb lips".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient presented to Hospital with swelling to the lips, tongue, face, and neck. Was able to breath adequately but was having difficulty swallowing and speaking. She was sent on to a hospital for further evaluation.
Chronic dizziness/Vertigo intermittently for 3-4 weeks so far. Sporadic  joint pain, muscle cramps, infrequent but intense for a few seconds at a time.
Child developed signs and symptoms of acute appendicitis on the day after the vaccinations. She underwent an appendectomy. DC DX for DOS 08/23-8/24/06:acute appendicitis without rupture and Ovarian cyst. Procedure performed:Laparoscopic appendectomy, aspiration of left ovarian cyst.
Pain, rash, itching, swelling and warm to touch at injection site.  It got a lot better after 2 days, but it's still there and more itchy now. General aches and fatigue mainly starting in the evenings.
Patient develop large round bump next day on shoulder and now has developed an even larger soft mass on the left elbow that is continuing to grow daily. Patient has been monitoring both masses, they are not red or warm to touch per my observation. Patient was instructed by myself to seek medical attention from a dermatologist or primary care physician for possible draining. Patient claims that neither area is painful, solely cumbersome.
chancre-variant cutaneous tuberculosis (TB) developed in response to the vaccination; BCG vaccine in an attempt to manage chronic migraines secondary to fibromyalgia; Information has been received from the authors of a literature, titled as stated above, referring to a 73-year-old female with a history of fibromyalgia. The patient had no history of immunosuppression and was not receiving immunomodulating therapy. Concomitant medication was not reported.  On an unknown date, the patient was vaccinated with bcg live (manufacturer unknown) (reported as BCG vaccine) (route, dose detail, lot number and expiration date were not reported) in the right arm as off-label therapy in an attempt to manage chronic migraines secondary to fibromyalgia (off label use).   On an unknown date, the patient presented with an ulcer of the right upper extremity that had been present for 3 months. The patient reported that the ulcer directly overlaid the BCG vaccination site. Skin biopsy from an outside clinic showed granulomatous dermatitis and positive staining for Mycobacterium bovis (M bovis); a culture had failed to grow any organism. On physical examination, the patient was well appearing and afebrile. A large, nontender, full-thickness ulcer with a hypertrophic base was present on the proximal right arm. Initial biopsy at the authors' institution revealed pseudoepitheliomatous epidermal and follicular infundibular hyperplasia with inflamed granulation tissue and confluent granulomatous infiltrates. Ziehl-Neelsen staining demonstrated numerous acid-fast bacilli (AFB) scattered throughout the granulomatous dermal infiltrate. The hypertrophic wound base was subsequently debulked, and a fluorescent smear of the tissue showed AFB. Tissue culture showed AFB after 3 weeks of growth. Tissue smear demonstrated 2 AFB to 18 AFB per 50 fields, and 12 colonies with a rough and buff appearance were recovered from Lowenstein-Jensen slant in week 6 of incubation. A nucleic acid amplification test detected ribosomal ribonucleic acid (RNA) of mycobacterium tuberculosis complex. This constellation of findings was consistent with localized M bovis infection. The patient was diagnosed with cutaneous tuberculosis, specifically tuberculous chancre (chancre-variant cutaneous tuberculosis), secondary to receiving the BCG vaccine. After surgical debulking, the patient was instructed to clean the wound base with saline every other day, pat it dry, and cover the area with an adhesive foam dressing. The patient was also started on isoniazid monotherapy 300 mg twice weekly. After 6 months of treatment, the wound was nearly healed (recovering). The reporter considered the event to be a vaccine side effect, which was related to the BCG vaccine.  Upon internal review, the event of chancre-variant cutaneous tuberculosis was determined to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.  Literature Report:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 21Mar2021 as dose 2, single (Lot number: GP7534), in left arm, on 05Nov2021 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 23May2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart and vascular blockages with stents" (unspecified if ongoing), notes: Other medical history: Heart and vascular blockages with stents and a heart valve replacement; "Heart and vascular blockages with stents" (unspecified if ongoing), notes: Other medical history: Heart and vascular blockages with stents and a heart valve replacement; "a heart valve replacement" (unspecified if ongoing), notes: Other medical history: Heart and vascular blockages with stents and a heart valve replacement. Concomitant medication(s) included: XARELTO; CARVEDILOL; ATORVASTATIN; BABY ASPIRIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: COVID 19 Treatment; (Sep2022) faint line, notes: Tested on Monday (Labor Day) and at first it looked clear but looking closer, there was a very, very faint line; (Sep2022) positive, notes: Decided to test and the positive line was quicker to show up and darker than any previous tests. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Sunday morning was last day of Paxlovid. Tested on Monday (Labor Day) and at first it looked clear but looking closer, there was a very, very faint line. No symptoms through Wednesday so I, thought I was clear. Thursday morning I started with a stuffy nose and thought it was allergies. Decided to test and the positive line was quicker to show up and darker than any previous tests. Putting our guard down, my wife was exposed more in the last couple of days. Symptoms are as bad or worse than the first, time around but got quick relief in a day the first time around.  Follow up attempts are completed. No further information is expected.
Patient received INFANRIX and PEDVAXHIB on 6/24/15 around 10:30 AM. Around bedtime patient developed fever. During the night, the patient vomited 2 times. Hives were noticed when patient awoke on 6/25/15.
Driving to work, pulled over to throw up. Twice on the way home. Only water and meds in my system . Called for a substitute, bought Sprite to sip, went to bed.
Patient was given the pediatric dose of Hepatitis A in error, he was 19 years of age so should have received adult dose. Talked to the Department of Health, they said to treat it as an invalid dose and to repeat the dose.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 17-JAN-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # N010706, expiry date: 02-DEC-2018) (route: oral). The vaccine was exposed to a temperature of 9 Cº to 25 Cº (8.3Cº) for 1 hour 17 min, on 06-JAN-2018, 9 Cº to 25 Cº (11.5Cº) for 1 hour 59 min on 11-JAN-2018, 9 Cº to 25 Cº (15.6Cº) for 1 hour 33 min on 17-JAN-2018, 9 Cº to 25 Cº (11.9Cº) for 1 hour 2 min on 23-JAN-2018 and 9 Cº to 25 Cº (12.1Cº) for 1 hour on 30-JAN-2018. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA002182: US-009507513-1802USA004634: US-009507513-1802USA004641: US-009507513-1802USA004647: US-009507513-1802USA004652: US-009507513-1802USA004654: US-009507513-1802USA004658: US-009507513-1802USA004663: US-009507513-1802USA004671: US-009507513-1802USA004673: US-009507513-1802USA004686: US-009507513-1802USA004692: US-009507513-1802USA004616.
I started to feel a lot of pain on my arm. My arm swelled up, I can't move it at all. My arm was also numb. I then had a bad headache, and I have a fever of 101.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 12-FEB-2015, the patient was vaccinated with an expired dose of M-M-R II (dose 0.5 ml, subcutaneous, lot # J000202, expiration date 09-JAN-2015). No adverse effects were reported. Product quality complain (PQC) was not involved. Additional information has been requested.
The pt developed shingles severe at left arm on 03/27/2002. Received varicella vaccine on 12/13/1996.
I had COVID in December 2020 and feel like I have it again: muscle aches (especially place of shot, but also in back); Chills; Fever; Generally just don't feel good; shortness of breath (I am a runner, so relatively healthy, but was short of breath just going from bed to chair); head ache.  From the moment I got it, it felt like my arm was going to fall off.  I got progressively worse throughout evening and woke up at some point last night with chills.  Definitely broke a fever, but it has come back throughout the day.
Product spent too long in transit and product was no longer suitable for use with no adverse event; Initial information received on 21-Sep-2021 regarding an unsolicited valid non-serious case received from a other health care profession and non-healthcare professional via [Medical Information under reference - 00778575].  This case involves a 100 patient's of (unknown demographics) were vaccinated INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] which went spent too long in transit and product was no longer suitable for use (product temperature excursion issue).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was given.  On an unknown date, the patient's received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot - UT7317KA and expiry date 30-06-2022) via an unknown route at an unknown administration site for prophylactic vaccination.  It was reported "she had a shipment of FLUZONE QUADRIVALENT which was shipped on Friday and delivered on Monday; caller states she was told that it spent too long in transit and product was no longer suitable for use. Caller states she has already administered this FLUZONE QUADRIVALENT to 100 patients post-excursion."  It was a case of actual medication error due to product temperature excursion issue.  At the time of reporting, no adverse event reported.  Outcome of event was unknown.   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 the 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 case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a adult male patient who received Flu Seasonal QIV Dresden for prophylaxis. The patient's past medical history included spinal operation, hepatitis C, arthritis (back arthritic issues) and spinal disorder. Previously administered products included ZEPATIER and ZOSTAVAX. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced injection site muscle pain and injection site erythema. On an unknown date, the outcome of the injection site muscle pain and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site muscle pain and injection site erythema to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: The age at vaccination was not reported. The patient reported that he suffered from Hepatitis C for the past 48 years that damaged his liver and for a three month period of 84 days he was taking an anti-viral medication by Merck called ZEPATIER. He also had suffered with spinal issues for many years including having back surgery and back arthritic issues. The patient also reported that he has had multiple flu shots over the years (manufacture and product name unknown) and he had experienced a little muscle soreness and redness at the injection site occasionally with the flu shot. The patient described this occurrence as happening once every several years but it was rare. The patient claims that he would be slightly sore for the next day and then it would resolve. He completed his treatment by 4th March 2018. The reporter gave consent to follow up. The patient refused to provide physician permission. This case has been linked with US2018198761, reported by same reporter for the same patient.
Initial misuse report received from a healthcare professional on 24 June 2013. An expired dose of ACTHIB was administered to a patient. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Menveo not properly reconstituted/not mixed with powder; administered only the liquid portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA703A, expiry date April 2023) for prophylaxis.   On 15th August 2022, the patient received the 1st dose of Menveo. On 15th August 2022, unknown after receiving Menveo, 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 Information: GSK receipt date: 29-Aug-2022 Reporter's comment: The pharmacist reported that the patient received Menveo vaccine that was not properly reconstituted and it was administered only the liquid portion without mixing it with the powder. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient was administered only the liquid portion without mixing it with the powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
"Covid arm" 8 days after shot. I got a dark spot first, then a rash developed. My arm swelled, got hot, and started itching and hurting. I called my PCP,  and he told me to go to urgent care right away. The urgent care doc said it was a localized delayed allergic reaction to the vaccine and the lymph nodes in my left armpit were swollen. I had a regular dr. appt 3 days later, and the doc said the lymph nodes in my neck were also swollen. Everything healed in about 10 days.
Local pain, swelling RUE near site Pneumovax within hours of injection. has improved but still some soreness, exam showed only tenderness.
approx 8hr post vax pt exp unresponsiveness episode x 4min w/hypotonia & blank staring followed by shaking of the hands, gasping for breath lasting apporox 14min total then resolved all other nl
Covid19 infection; lack of drug effect; Messed up her blood sugar; Messed up her zinc; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid19 infection), BLOOD GLUCOSE ABNORMAL (Messed up her blood sugar), BLOOD ZINC ABNORMAL (Messed up her zinc) and DRUG INEFFECTIVE (lack of drug effect) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal, Diabetes and Thyroid disorder. Concomitant products included METFORMIN for Diabetes.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced COVID-19 (Covid19 infection) and DRUG INEFFECTIVE (lack of drug effect). In September 2021, the patient experienced BLOOD GLUCOSE ABNORMAL (Messed up her blood sugar) and BLOOD ZINC ABNORMAL (Messed up her zinc). At the time of the report, COVID-19 (Covid19 infection), BLOOD GLUCOSE ABNORMAL (Messed up her blood sugar), BLOOD ZINC ABNORMAL (Messed up her zinc) and DRUG INEFFECTIVE (lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2021, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered BLOOD GLUCOSE ABNORMAL (Messed up her blood sugar) and BLOOD ZINC ABNORMAL (Messed up her zinc) to be unlikely related. No further causality assessments were provided for COVID-19 (Covid19 infection) and DRUG INEFFECTIVE (lack of drug effect).    Patient received Moderna vaccine at Vaccine facility Kroger K426, GA, US  Other concomitant medications included unspecified statin, unspecified blood pressure medication and thyroid medication.   Treatment medication included unspecified steroid for COVID-19 which messed up patient's  blood sugar and zinc.; Sender's Comments: This case concerns a 70-year-old female patient with  history of Diabetes and Thyroid disorder, who experienced the non-serious  unexpected event COVID-19 (AESI). The event occurred approximately 7 months after second dose of mRNA-1273 Moderna vaccine.  Lack of drug effect  was also captured as an event. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
Welt around upper arm, itching, swelling, bruising, extreme pain (not just at injection site), warm to touch.
approx 72hr p/vax started w/T102 & sz tonic clonic gen x 3 <2min each;
Narrative:  Taken to ER for monitoring - was stable, SpO2 95%, clear speech, stated he felt new lump in throat
PATIENT EXPLAINED THAT HE HAS SLIGHT DIZZINESS DUE TO BEING NERVOUS ABOUT THE SHOT. THE PATIENT WAS SEATED AND EXPLAINED THAT HE FELT MUCH BETTER. THE PATIENTS PARENTS EXPLAINED THAT THEY WOULD TAKE PATIENT HOME AND MONITOR.
Daily urticaria, persistent as of today, 7 weeks after dose 2 of Covid vaccine.  Urticaria improves with antihistamine medication, but recurs as soon as medication wears off.