chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diagnosed with PMR with GCA; Diagnosed with PMR with GCA; Temporal pain; jaw pain; body pain; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Dec2021 at 14:00 as dose 1, single (Lot number: 33030) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: POLYMYALGIA RHEUMATICA (medically significant), GIANT CELL ARTERITIS (non-serious) all with onset 27Dec2021 at 14:00, outcome "unknown" and all described as "Diagnosed with PMR with GCA"; HEADACHE (non-serious) with onset 27Dec2021 at 14:00, outcome "unknown", described as "Temporal pain"; PAIN (non-serious) with onset 27Dec2021 at 14:00, outcome "unknown", described as "body pain"; PAIN IN JAW (non-serious) with onset 27Dec2021 at 14:00, outcome "unknown", described as "jaw pain". The events "diagnosed with pmr with gca", "temporal pain", "jaw pain" and "body pain" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Negative, notes: Other. Therapeutic measures were taken as a result of polymyalgia rheumatica, giant cell arteritis, headache, pain in jaw, pain.  Clinical Course: Age group reported as (18-64 Years). Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. Other medications in two weeks: Na. Adverse event: Temporal pain, develop to jaw pain then body pain. Diagnosed with PMR with GCA. No covid prior vaccination. Covid was tested post vaccination. Prednisone was given as treatment for AE. No Other medical history. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Covid test post vaccination, type: Other, test name Home kit.; Sender's Comments: Based on the available information in the case, the causal association between the event polymyalgia rheumatica and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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.
A serious report of septic arthritis has been received from a study investigator concerning a 39-month-old female participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 19-Nov-2008, the subject received FLUMIST. The subject was admitted to the hospital for septic arthritis on 16-Dec-2008. The length of stay was three days. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the events was moderate. The sponsor also assessed the causality for the event as not related to FLUMIST.
Development of painful generalized paresthesia - burning, pins and needles, stabbing involving both hands, arms, chest, face thighs. Paresthesia progressed in intensity worse in the evenings and nights. I have preor small fiber peripheral biopsy possibly autoimmun diagnosed by skin biopsys and normal nerve conduction.
COVID test on 13Jan21 resulted as positive; COVID test on 13Jan21 resulted as positive; Symptoms of sore throat, Nausea/Vomiting/ Diarrhea; Symptoms of sore throat, Nausea/Vomiting/ Diarrhea; Symptoms of sore throat, Nausea/Vomiting/ Diarrhea; Symptoms of sore throat, Nausea/Vomiting/ Diarrhea; This is a spontaneous report from a contactable pharmacist. A 34-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was EL1284 and expiration date was not reported; 34 year age at time of vaccination), dose 1 intramuscular, administered in arm left on 23Dec2020 at 13:30 as single dose for covid-19 immunisation. The patient medical history included tested COVID+ on 13Nov2020 following household exposure. Concomitant medications included salbutamol (albuterol) at unknown dose at every 4 hrs (q4h prn) for sob (shortness of breath)/wheezing, citalopram and clonazepam. The patient known allergies included sulfadiazine (hives) and bananas (throat swelling). The patient previously had allergy to sulfadiazine (hives), bananas (throat swelling). other medications in two weeks: albuterol mdi q4h prn sob/wheezing, citalopram (unknown dose), clonazepam (unknown dose). Received first COVID vaccine 23Dec2020. Symptoms of sore throat, Nausea/Vomiting/ Diarrhea started on 12Jan21 08:00 prior to receiving her 2nd vaccine dose. COVID test on 13Jan21 resulted as positive. Patient not received treatment. Patient had covid prior vaccination (COVID+ on 13Nov2020 following household exposure); patient was covid tested post vaccination; covid test post vaccination covid test type post vaccination=Nasal Swab; covid test date=13Jan2021; covid test result=Positive. The outcome of the events was resolved in 2021.; Sender's Comments: Considering a plausible temporal relationship and known product safety profile, a possible contributory role of suspect product Comirnaty to the reported 'COVID 19' cannot be completely excluded.
Pt. received her 2nd Hep B vaccine at 8:30 AM at 10:15 she felt nauseated, headache-blurred vision with loss of sight at periphery. Describes scintillating, scotoma vomited x 1 feels she is flushed T. 97.9 VS 140/90 P. 92 O2S at 97% lungs clear.
Immediately after second dose:  injection site pain, body aches, extreme fatigue, nausea, trouble breathing  One month after second dose:  early onset menstrual cycle, heavy bleeding, intense flow/clotting, hemorrhage-like event, prolonged period (over 7 days)
Pt recv vax on 8/11/97; on 9/5/97 pt exp pain at vax site & pain kept pt awake; tx=analgesics, NSAIDS, heating pad
Chest pains and chest tightness, on and off over the course of the 24 hours following the vaccine, starting about an hour after receiving the vaccine.  The chest pains are mild, but uncomfortable.
flares; Nasal congestion; headaches; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (flares), NASAL CONGESTION (Nasal congestion) and HEADACHE (headaches) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TOFACITINIB CITRATE (XELJANZ) from 01-Feb-2021 to an unknown date for Rheumatoid arthritis, FLUTICASONE PROPIONATE, KETOTIFEN FUMARATE, MACROGOL 400, PROPYLENE GLYCOL (SYSTANE), TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), ACICLOVIR SODIUM (ACYCLOVIR), CICLOSPORIN (RESTASIS MULTIDOSE), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), SALBUTAMOL SULFATE (VENTOLIN HFA), ALBUTEROL SULFATE, RANITIDINE HCL and METHYLPREDNISOLONE ACETATE (METHYLPREDNISOLONE) for an unknown indication, VITAMIN D3.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (flares), NASAL CONGESTION (Nasal congestion) and HEADACHE (headaches). At the time of the report, ARTHRITIS (flares), NASAL CONGESTION (Nasal congestion) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was instructed by md to stop taking XELJANZ one week before and one week after each vaccine dose. Patient reports during the time not taking XELJANZ he had flares and nasal congestion   This case was linked to MOD-2021-104951 (Patient Link).
This patient originally received a influenza vaccine on 09/19/2023. The patient has a significant language barrier and has lack health literacy and presented to clinic on 09/28/2023 for vaccination records, but made it seem as if they were presenting for an influenza vaccine.  A relatively new clinic staff member did not remember to check the vaccination record prior to administering the vaccine, and administered a second influenza vaccine on 09/28/2023.  This staff member has been spoken to and reminded to check records ( as dictated by clinic policies and agency policies) prior to administering. The staff member will complete additional required training prior to next administering vaccines.
My menstrual cycle is currently a week late.  I also started to experience increased hair shedding about 2 weeks after my last shot.
Dr walked into employee health requesting steroids. States has already taken Benadryl. Reddened rash with hives noted arms and neck. States he doesn't want to go to the ER just needs RX for steroids. Noted to his coworkers, RX number given. Rec'd Covid vaccine on 12/20/2020
Painfully itchy and pain down the arm and into arm pit.; Swelling, large red spot surrounding injection site; Swelling, large red spot surrounding injection site; Painfully itchy and pain down the arm and into arm pit.; Painfully itchy and pain down the arm and into arm pit; This is a spontaneous report from a contactable other hcp (patient). A 30-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number Fa7485), dose 2 via an unspecified route of administration, administered in Arm Left on 16Jul2021 16:30 (at the age of 30-year-old) as DOSE 2, SINGLE for covid-19 immunization. No other vaccine in four weeks. Medical history included fibromyalgia from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, seasonal allergy from an unknown date and unknown if ongoing Wellbutrin, morphine, seasonal, mold, dust, grass and bleach, mycotic allergy from an unknown date and unknown if ongoing Wellbutrin, morphine, seasonal, mold, dust, grass and bleach, dust allergy from an unknown date and unknown if ongoing Wellbutrin, morphine, seasonal, mold, dust, grass and bleach, seasonal allergy from an unknown date and unknown if ongoing, Wellbutrin, morphine, seasonal, mold, dust, grass and bleach, allergy to chemicals from an unknown date and unknown if ongoing, Wellbutrin, morphine, seasonal, mold, dust, grass and bleach. Concomitant medication(s) included colecalciferol (VIT D3) taken for an unspecified indication, start and stop date were not reported; ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]) taken for an unspecified indication, start and stop date were not reported. The patient previously took bnt162b2 for covid-19 immunisation, wellbutrin and experienced drug hypersensitivity, morphine and experienced drug hypersensitivity. On 17Jul2021 20:00 the patient experienced painfully itchy and pain down the arm and into arm pit, swelling, large red spot surrounding injection site, painfully itchy and pain down the arm and into arm pit. No covid prior vaccination, and no covid tested post vaccination. The outcome of events was unknown.  Follow-Up (01Sep2021): Follow-up attempts are completed. No further information is expected.
A non-serious spontaneous report of patient received expired FLUMIST was received from a health professional concerning a 10-year-old Female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 20-Feb-2011. On 28-Feb-2011, the patient received the expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Intense vomiting; Ongoing nausea; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Intense vomiting) and NAUSEA (Ongoing nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-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 VOMITING (Intense vomiting) and NAUSEA (Ongoing nausea). At the time of the report, VOMITING (Intense vomiting) and NAUSEA (Ongoing nausea) had not resolved.            Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
sore arm; The initial case was missing the following minimum criteria: there is no indication that the patient experienced an event under suspect product. Upon receipt of follow-up information on [26Oct2021], this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. Relevant medical history included: "allergy to propylene glycol" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She says she has never had a reaction to it. She knows that polyethylene glycol is contained in the Pfizer Covid vaccine and wants to know what the difference is between the two compounds. Caller is asking for guidance on how to get the vaccine in her area. She only got a sore arm from the vaccine and does not want to be contacted any further.  Follow-up (26Oct2021): This is a follow up spontaneous report from a contactable consumer. Upon receipt of follow-up information this case now contains all required information to be considered valid. This consumer reported in response to Non HCP letter sent via telephonic follow-up activity which included that: new adverse event and other information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A non-serious report of expired FluMist administered has been received from a nurse concerning a teenage female. No medical history nor concomitant medications were provided. The patient, her mother, and her two teenage siblings received FluMist on 27-Dec-2007. The expiration date on the FluMist was 25-Dec-2007. No adverse event was reported nor on 21-Feb-2008 when contacted for follow-up. The event was resolved on 27-Dec-2007. The reporter was provided information regarding additional dosing of the product when a patient is inadvertently administered product after the expiration date. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is liked to the cases for the patient's mother and two teenage sibling who also received expired FluMist: MEDI-0006351; MEDI-0006353; MEDI-0006354. Additional information received on 21-Feb-2008 and incorporated into the narrative: No adverse even experienced.
Patient was administered Pfizer vaccine and immediately had a Vasovagal syncope event.  Patient fell from a standing position and impacted head to floor. Patient regained conscious within 10sec, able to speak full clear sentences, A&Ox4, denied any pain, no gross deformity, bruising, or trauma noted. EMS notified and ambulance arrived to transport patient to ED for further evaluation. ED physician evaluated patient, performed EKG and Lab work and released patient to full care at home.  Vital Signs following return to consciousness: BP: 110/80 HR: 80 RR: 16 on room air  Due to the head impact and concern for greater evaluation. EMS Fire was notified. EMS arrived at 0910, assessed patient and agreed with determination for no cervical or lumbar pain. EMS allowed patient to ambulate to ambulance.   Patient did not receive any medication during event and syncope resolved spontaneously.
p/receiving vax pt c/o rash all over, transcient neuralgia, arthralgia & gen malaise sx;pt denied prior rxn to hep B vax;
3/13: fever and chills; ibuprofen taken 8pm 3/14: 12:30am: fever and chills, acetaminophen PO 5am: fever and chills, acetaminophen PO low back pain, flank pain, hip pain, fatigue, dyspepsia, no appetite all day, Tylenol q4h highest temperature 100.9 3/15: fever and chills till 12pm, dyspepsia, no appetite, mouth sore, bleeding gums, fatigue 3/16: dyspepsia, no appetite, headache, vaginal inflammation with white patches 3/17: dyspepsia, no appetite, headache, vaginal inflammation with white patches 3/18: dyspepsia, no appetite, headache, vaginal inflammation resolved
Flare up of the arm; Felt bad; 7 patients for a late second dose of Shingrix over 6 months, with one of those patient being due today; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rash, feeling bad and incomplete course of vaccination. On an unknown date, the outcome of the rash, feeling bad and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the rash and feeling bad to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient flare up of the arm and felt bad after the 1st dose of Shingrix and late for second dose of Shingrix over 6 months, which led to incomplete course of vaccination.  HCP unable to provide full patient details. The reporter did not consented to follow up.  This was 1 of 7 cases, reported by the same reported.
patient came this morning 4/26/23 and informed us that he experience a local reaction after getting the flu vaccine on 4/23/23. I examined the injection site. there are about 3 little area that seems red and inflame and one little blister is still there. Patient said that the rashes appear on Monday. I asked if patient has gotten flu vaccine before, he said yes without any reaction. I think that the patient might be allergic to the adhesive from the bandage, but I'm not too sure. Patient does not speak clear language, so it was a bit challenging to get answer from him. I advised him to apply Neosporin ointment two to three times daily. If the rash is not getting better in couple of days or spread bigger, patient is to call us.
never been sicker in; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The patient received the flu shot once, required for work and never been sicker in patient's life. The patient stated no vaccine. No other information was provided. The reporter did not consent to follow up.
This report describes the occurrence of lethargy in an approximately 3-month-old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  This report was received from the subject's mother, who is a nurse.  The subject reportedly had no relevant medical history, concurrent conditions, or concurrent medications.  On 12/17/2002, the subject received his first injection of Infanrix.  On that same date, he also received injections of inactivated poliomyelitis virus vaccine (IPOL), and Haemophilus influenzae type b conjugate vaccine (manufacturer unknown).  At an unspecified time post-immunization, on 12/17/2002, the subject reportedly began to experience intermittent and recurrent inconsolable crying and lethargy.  The nurse considered the events to be probably related to Infanrix administration.  The events resolved on 12/26/2002.
She reported that she developed chills and fatigue about 4 hours after vaccine. Followed by several episodes of diarrhea that continued to the following day. No documented fever but she had chills and sweats. Also reported itching of neck and torso with redness and fine popular rash on neck and chest (not seen in office the day patient was seen by me on 10/5/18). The patient was afebrile and had normal stools on 10/5/18 and was feeling better.
This spontaneous report was received from a medical assistant referring to a 12 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 02-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with lot # N002720 and expiration date 12-MAY-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning GARDASIL 9 with lot # M036059. On 11-MAY-2017 at 12:24, the time in the range 32° Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009211 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009211 is being deleted from our files and the case is consolidated into case # 1711USA003911 with the correct Aware Date 18-SEP-2017. Sender's Comments: US-009507513-1708USA011654.