chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in right knee left hip; dizzy, light headed; Not sleeping very well; balance off; could feel heart beating hard; pain in right arm; tiny bit of swelling in throat; burning in chest; burning in back from waist to neck; arm pain that went around the shoulder and base of neck; fatigue; vertigo that felt like a floating feeling but is better in the evening; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), ARTHRALGIA (pain in right knee left hip), VACCINATION SITE PAIN (pain in right arm), PHARYNGEAL SWELLING (tiny bit of swelling in throat) and CHEST PAIN (burning in chest) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE E) for Skin irritation.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced FATIGUE (fatigue), VACCINATION SITE PAIN (pain in right arm), PHARYNGEAL SWELLING (tiny bit of swelling in throat), CHEST PAIN (burning in chest), BURNING SENSATION (burning in back from waist to neck), PAIN IN EXTREMITY (arm pain that went around the shoulder and base of neck) and PALPITATIONS (could feel heart beating hard). On 21-Jan-2021, the patient experienced BALANCE DISORDER (balance off). On an unknown date, the patient experienced ARTHRALGIA (pain in right knee left hip), DIZZINESS (dizzy, light headed), VERTIGO (vertigo that felt like a floating feeling but is better in the evening) and POOR QUALITY SLEEP (Not sleeping very well). On 13-Jan-2021, PHARYNGEAL SWELLING (tiny bit of swelling in throat), CHEST PAIN (burning in chest) and BURNING SENSATION (burning in back from waist to neck) had resolved. On 15-Jan-2021, PAIN IN EXTREMITY (arm pain that went around the shoulder and base of neck) had resolved. At the time of the report, FATIGUE (fatigue), ARTHRALGIA (pain in right knee left hip), VACCINATION SITE PAIN (pain in right arm), DIZZINESS (dizzy, light headed), BALANCE DISORDER (balance off), PALPITATIONS (could feel heart beating hard) and POOR QUALITY SLEEP (Not sleeping very well) outcome was unknown and VERTIGO (vertigo that felt like a floating feeling but is better in the evening) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
13 year old patient was inadvertently given MMRV instead of MMR and Varicella separately. MMRV is indicated for children 1-12 years of age. I spoke with Immunization Registry, and they reported there is no need for further immunization or treatment needed. I also spoke with mom and explained situation to her-mom reports mild erythema in very small area around injection site and some slight tenderness, but no other symptoms.
This spontaneous report was received from a medical assistant referring to a 12 year old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 20-MAR-2018, the patient was administered an improperly stored GARDASIL 9 (lot: N026814; Expiry date: 15-JUL-2020 and lot: N021572; Expiry date: 01-MAY-2020) (product storage error) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 47 °F to 77°F (67.3°F) for 10 hours, 30 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several cases received from the same reporter.
Information has been received from a registered nurse concerning a 17 year old patient (gender not reported) who on 19-NOV-2007 was vaccinated with a first dose of GARDASIL.  The nurse reported that on an unspecified date the patient had itching after the first dose of GARDASIL that lasted until the second dose was given (date unspecified).  The patient than had a rash and itching with the second dose (date unspecified).  The third dose has not been given yet.  At the time of reporting it was unknown if the patient had recovered.  No further information was available from the nurse.  Additional information has been requested.
knots in my bottom lip and top lip; Eyes swelled up; Eyes popped out; Lips swelled up; Throat swelled out; This spontaneous case was reported by a consumer and describes the occurrence of LIP DISORDER (knots in my bottom lip and top lip), EYE SWELLING (Eyes swelled up), EYE DISORDER (Eyes popped out), LIP SWELLING (Lips swelled up) and PHARYNGEAL SWELLING (Throat swelled out) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043D21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced LIP DISORDER (knots in my bottom lip and top lip), EYE SWELLING (Eyes swelled up), EYE DISORDER (Eyes popped out), LIP SWELLING (Lips swelled up) and PHARYNGEAL SWELLING (Throat swelled out). The patient was treated with EPINEPHRINE (intravenous) for Adverse event, at an unspecified dose and frequency. At the time of the report, LIP DISORDER (knots in my bottom lip and top lip), EYE SWELLING (Eyes swelled up), EYE DISORDER (Eyes popped out), LIP SWELLING (Lips swelled up) and PHARYNGEAL SWELLING (Throat swelled out) outcome was unknown.            Concomitant product was not provided by the reporter.   This case was linked to MOD-2021-297314 (Patient Link).
Patient self-reporting through the hospital's electronic reporting system.  In her own words, "Received 2nd Pfizer COVID-19 Vaccine.  Beginning 17 hours later, I had extreme weakness, headache, chills and fever. I had to take off Friday, January 22, 2021, from work because of not feeling well.  I still am not feeling well".
I got the flu two weeks later; Initial information was received on 29-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via social media.  This case involves an unknown demographics patient who experienced flu two weeks later (influenza) after receiving vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu two weeks later (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  It was reported "Flu Shot Fridays last time I got the flu shot I got the flu two weeks later. Bull Crap."  It was not reported if the patient received a corrective treatment for the events.  At the time of reporting, the outcome of events was reported as unknown.  There will be no information available on the batch number for this case.
Pain and mild swelling in/near injection site (right arm) of Engerix-B vaccine. Pain increased day after vaccination.
This spontaneous report was received from a 82 year old female patient reporting on herself, who is also a Registered Nurse. The patient concurrent conditions and medical history included hypertension, hypercholesterolaemia, hypothyroidism, arrhythmia and allergy to AUGMENTIN. On 03-MAY-2016, the patient was vaccinated with a dose of ZOSTAVAX (dose number, strength, route, lot number and expiration date were not provided). Concomitant therapies included lisinopril (manufacturer unknown), SYNTHROID, amiodarone, and LIPITOR. On 04-MAY-2016, the patient experienced mild headache and lightheadedness (dizziness). TYLENOL was given for the adverse events. The outcome of headache and dizziness was reported as recovering. The case did not involve cancer or overdose. The reporter did not assess the relatedness between the event and suspect therapy. No product quality complaint was involved. Additional information has been requested.
Pt became nauseated and vomited while getting into his car to go to lunch. Pt was brought in by his supervisor and reported to flight medicine. pt was given 1L of NS, given promethazine, and observed until his recovery at about 1430 and released to his supervisor to return home.
Administration site redness and pain. Pain throughout upper arm. Hardness at administration. Fever/chills.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Vaccines were stored in refrigerator on 18 Oct 2021 and no temperature excursion noted.  Treatment medications were not reported.   This case was linked to MOD-2022-491837 (Patient Link).
5:00pm experiencing headache, fatigue, cold chills 7:00pm nausea, vomiting, cold chills, body aches, head aches Lasted until 6:00 1/24/21
The Patient  came to the vaccine clinic to obtain his first dose of Moderna at about 2.10pm.Pt was accidentally given 0.25ml  instead of 0.5ml.Pt was offered  to receive the remining dose of 0.25ml on the right  hand but;He  declined and stated he will come next week to receive the remining 0.25ml for the first dose. No adverse effect to the vaccine occured
discomfort at the injection site; stiffness; This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number CL335, expiry date unknown) for prophylaxis.   On 16th September 2020, the patient received the 1st dose of Shingrix. On 16th September 2020, 30 min after receiving Shingrix, the patient experienced injection site discomfort and stiffness. On 16th September 2020, the outcome of the injection site discomfort and stiffness were recovered/resolved.   It was unknown if the reporter considered the injection site discomfort and stiffness to be related to Shingrix.  Additional information was provided as follows: This case was reported by patient himself. The patient received 1st dose of Shingrix in left deltoid and experienced discomfort at the injection site and stiffness which both started about a half hour after the vaccination was received and which were resolved 2 hours after the vaccination. The patient did not ask any questions about Shingrix but gives consent to email Shingrix PI (package insert). The reporter gives consent to follow up with his healthcare professional. The reporter consented to follow up. For the tolerance of 2nd dose, refer case- US2021AMR063144, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063144:same reporter
About 4 hours after the vaccine my left eye started to get very red & swollen; About 4 hours after the vaccine my left eye started to get very red & swollen; Numbness on the left side of my face; Swelling on the left side of my face; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 60-years-old male patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in Arm Left on 07Mar2021 at 12:30 as SINGLE DOSE for covid-19 immunization (Facility type vaccine: Pharmacy or Drug Store). The patient's mdical history was reported as none. Patient has been not taking any other vaccine in four weeks. And no other medications in two weeks. Patient has not tested covid-19 positive prior to vaccination. Patient has no known allergies. It was reported as on 07Mar2021 at 04:30 PM about 4 hours after the vaccine his left eye started to get very red and swollen along with some numbness and swelling on the left side of his face. Four hours later it was started to get better with cold compress. Patient has not tested covid-19 positive post vaccination. The outcome of the events was reported as resolving.   No follow-up attempts are possible. No further information is expected.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 16-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 25-Dec-2011. On 04-Jan-2012, the patient inadvertently received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 21-Mar-2012 and incorporated into the narrative: No late occurring adverse event.
ACID REFLUX; RASH; This spontaneous report received from a consumer 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, Expiry: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced acid reflux, and rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash and acid reflux was not reported. This report was non-serious.
Patient received vaccine through drive through clinic. Patient was driving his truck and seemed to veer off, a vaccinator noticed and ran to truck, writer then followed. Initial person told patient to park the truck. Patient appeared to be snoring and un responsive but did put truck in park. Sternal rub was preformed and patient began to come to, seemingly disoriented. Patient was evaluated by EMS in ambulance but no transfer happened. Patient was incontinent as well.  Patient states this happens after he gets injections or lab work done but did not disclose this to the vaccinators at time of vaccine administration.
pt recv vax & 5min later devel cough, nasal congestion & wheezing;
Myocarditis; This is a literature report.  A 66-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovered". The patient underwent the following laboratory tests and procedures: Angiogram: normal; Chest X-ray: normal; Electrocardiogram ST segment: abnormal, notes: ST elevation; Magnetic resonance imaging: ant. septum in the mid-ventricular level, notes: Enhancement (myocardial and epicardial) along the ant. septum in the mid-ventricular level (LVEF: 44%).  Clinical information: Patient's presentation included Crushing substernal chest discomfort, diaphoresis, emesis.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event and suspect drug BNT162B2 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.
This spontaneous report as received from a Licensed Practical Nurse (LPN)other health professional refers to a patient of unknown age. The nurse reported that the patient received their thrd dose of GARDASIL 9 earlier than the recommended interval. On 23-NOV-2016,the patient was vaccinated with GARDASIL 9 and on 17-FEB-2017 was  vaccinated with third dose of GARDASIL 9. No adverse effects were reported and no further information was provided. The outcome of inappropriate schedule of drug administration and no adverse event is unknown.    Additional information has been requested.
right after vaccine given, Pt c/o stomach ache , went home and vomited a few times and again in the am. no fever, no diarrhea. supportive measures provided .
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 at 12:00 as dose 3 (booster) , single (Lot number: FH8020), in right arm and on 31Mar2022 at 18:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 77 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2 , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lung cancer" (unspecified if ongoing), notes: Lung cancer; "Chemo/radiation summer of 2020", start date: 2020, stop date: 2020, notes: Chemo/radiation summer of 2020.; "immunotherapy" (ongoing), notes: Currently monthly immunotherapy. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jun2022) negative, notes: Home Covid test on 22Jun2022-negative; (23Jun2022) positive, notes: Home Covid test 23Jun2022-positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient didn't taken any other medication in 2weeks. Home Covid test on 22Jun2022-negative. Sore throat, slight headache 25Jun2022. Home Covid test 23Jun2022-positive. Symptoms now include some loss of smell, taste, mild fever, itchy throat. No symptoms during first Covid.  No follow-up attempts are possible. No further information is expected.
Patient presented to the ED and was subsequently hospitalized twice within 6 weeks after receiving COVID vaccination. DOS were 2/22/21 and 2/26/21.
I awoke to pain all over my body, and was either too hot or too cold, and could not sleep because of the discomfort.  At 2p on 04/10/2021, the pain and chills stopped.  I slept from then until 7a today (04/11/2021).  Today I feel good, but feel like I had a really hard workout yesterday.
Case number PHHY2013US080932 is an initial spontaneous report received from a nurse on 26 JUL 2013. This report refers to a 20-year-old male patient. He was given only the Men A component of MENVEO (batch number A12131) intramuscularly on 26 JUL 2013. MenA was reconstituted with sterile water instead of MenCYW-135. No adverse event was reported following this administration error (wrong solution used in drug reconstitution).
onset itchy bumps vicinity of inject sit x 2 days p/inject progr inc # bumps w/some spread esp into back;
received one Shingrix dose for sure / not sure about second dose / appointment / for a SHingrix shot on Jun 12th 2021 but thyey don´t know for what is this.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date). Concurrent medical conditions included immunodeficiency.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at the vaccination was not applicable. The pharmacist reported for an immunocompromised patient who received Shingrix 1st dose for sure but he was not sure about the 2nd dose because he moved. The patient had appointment in a pharmacy for Shingrix shot on 12th June 2021 but did not know for what it is. There was no information available about Shingrix shot dose given for sure, which led to incomplete course of vaccination. The reporter consented to follow up.
Mild face swelling; Tingling in throat; This is a spontaneous report received from contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received 1st dose in the morning, then  in the afternoon they had some mild face swelling and tingling in throat. She did have a dentist appointment that afternoon and they referred her to the ER. The ER did not document any anaphylactic reaction. The patient was fine and they sent her home. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
The day after she received vaccination, she started developing erythema and swelling on the site of injection, which became tender, and started spreading slowly over deltoid area. When seen 3 days after vaccination, had cellulitis developed on right deltoid area, 3 fluctuation/abscess. I do not believe this was a reaction of vaccine per se, as any injection can break skin and become a site of entry to S. aureus infection.
Started with rash on both forearms, moved to become a rash on both legs as well. Itches, but bearable.  No respiratory or throat involvement. Patient will treat with Benadryl now.