chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller states he feels "a little sore" at the injection site, but not very much.; 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 77 year-old male patient 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: MYALGIA (non-serious), outcome "unknown", described as "Caller states he feels "a little sore" at the injection site, but not very much.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
01/26/21 ct felt swollen lymph node, R armpit/breast, in arm vaccine given, denied redness. 2-1-21 , had U/S, mammogram x 3, biopsy of lymph node, 2x size of lymph node of L arm. Ct developed hives from Iodine prep used prior to bx, pink rash remains where Iodine used, never reacted to iodine before. 02/06/21- iodine hives, tx w/ steroids. On 2/10 consult w/ Oncologist, Bx/aspiration inconclusive, suspicious for malignancy, recommended to have lymph node removed for further evaluation, has f/u with Oncologist March 24th. Since 02/20 client unable to feel the swollen lymph node, ran 5 miles today. HCP unsure if reaction r/t vaccine, unsure to get 2nd dose Moderna, currently being postponed.
sore arm; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 08Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 09Mar2021, outcome "unknown", described as "sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
White blisters on the lips after 2 weeks of vaccination; A series of 3 white bumps, not opensores.; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 02Mar2021 at 12:45(at the age of 66-year-old), as a single dose for COVID-19 immunisation. Medical history included cold sores. The patient had a history of allergy to tetracycline. Concomitant medications included progesterone (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID), estradiol (MANUFACTURER UNKNOWN) , estradiol (ESTROGEN) all from an unknown date for an unknown indication. The patient previously took first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 13Feb2021 at 13:15 (at the age of 66-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Mar2021 at 08:00, the patient experienced 3 white bumps on lips and 3 white blisters on the lips after 2 weeks of vaccination. The patient had the worst and weirdest occurrence ever had on lip. At age 66, the patient perhaps typically has an outbreak maybe once a year, following a cold. It lasts may be a week, and has a typical appearance. This appearance, occurring almost 2 weeks after the vaccine, looks like nothing ever seen on lip and was still there. A series of 3 white bumps, not open sores. They were still present, though very small. The next day another occurrence of 3 white little blisters (no open sores) appeared on another part of lip. The patient promptly took valacyclovir and applied acyclovir on it and they were gone in the morning on the day of report, though the original was still present. The patient has never seen sores like this, nor have those and have had ever lasted more than a week or so and was incredibly weird. The patient already have medication for cold sores, so did not go to the doctor and so much on hand because the patient never have had to use it before. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of event and included treatment with valacyclovir and an ointment acyclovir. The clinical outcome of the event's 3 white bumps on lips and white blisters on the lips after 2 weeks of vaccination was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
8/29/2023 - 8/31/2023 (2 days) Date of Admission: 8/29/2023  Discharge Date: 08/31/23 Discharge Disposition: Home or Self Care  history of generalized depression, neuropathy, chronic pain, patient was brought into the emergency department due to overall generalized weakness, mechanical fall last night secondary to overdosing on gabapentin.  Patient without oxygen requirement. The patient is currently asymptomatic. No indications for COVID-19 specific therapy.    9/2/2021 Pfizer, Inc FV3183 8/12/2021 Pfizer, Inc FA7484 4/13/2022 Pfizer, Inc FK9895
Initial report received on 1/31/06 from a health care professional. A 16 month old  male pt with no significant medical history had received an administration (route not reported) of Tripedia, lot number U1345BA, in the left thigh and an administration (route not reported) of another manufacturers varicella vaccine Varivax, lot number 1023R, in the right thigh on 1/30/2006. That same day (time not reported) the pt developed left upper thigh redness, rash, edema and complained of soreness at the site. At the time of this report the pt had recovered from these events. The reporter for this case is the same as for case number 2006-00226. Follow up information received on 4/10/06. Per responsible physician the pt had no adverse events reported after previous immunizations and no immunizations were received within 4 weeks of the administration of Tripedia on 1/30/06. After receiving the IM injection of Tripedia, which was the pts fourth dose, not fifth as previously reported, the phys reports that the pt was also feverish. On set time and temperature was not reported. An ultrasound was performed on 1/31/06 which showed some fluid in the area, but no abscess. Advised to use warm compresses QID and given Motrin 125 MG Q 8 hours for pain. No further information expected.
Experienced an adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Experienced an adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Experienced an adverse reaction). At the time of the report, VACCINATION COMPLICATION (Experienced an adverse reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       During follow-up patient told she had side effect but feeling fantastic. She did not see any doctor.  Concomitant medication information not provided. Treatment given not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: No specific follow-up information recorded.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested
The patient is a 72-year-old female who received a Shingrix vaccine on August 29, 2019. This was administered in her left upper extremity at the pharmacy. Following day patient complained of nausea headaches and arthralgias. She also had pain at the injection site without erythema or edema. Later that evening patient developed diffuse hives, cyst and swelling involving "my lips my tongue in the top of my throat." Patient presented to the Emergency room where she was treated with IV Benadryl and corticosteroids. Patient was discharged on oral prednisone and Benadryl. The hives increased later that day and the patient returned to the Emergency Room. However she did not wait to be seen due to long wait time. I spoke with the patient on the morning of September 1st. I increased her prednisone dose 60 mg that day and we tapered by 10 mg daily. Patient took 20 mg of prednisone this morning. Since that time patient denies recurrent hives. Patient states "overall I fell okay now."
Afluria Quadrivalent was administerd via subcutaneous route instead of intramuscular; Redness at injection site; This is a spontaneous case from initially reported by other health professional to agency (reference number: SEQ19-04419) on 10-Oct-2019, concerning 52-year old female patient.  The patient's medical history and concomitant medications were not reported.  On 10-Oct-2019, the patient was administered Afluria Quadrivalent [influenza vaccine; dose: 0.5 ml, route of administration: subcutaneous, anatomical location: right arm; batch number: P100123050; expiration date: 30-Jun-2020] (explicitly coded as Inappropriate route of vaccination') for influenza prophylaxis.   On the same day, after vaccination, the patient experienced redness at injection site.  The reporter inquired what was needed to be done and was offering revaccination, but the patient was not revaccinated.  On an unknown date in Oct-2019, the redness at injection site was resolved.   This case is linked to: 201905179, 201905181, 201905182, 201905183, 201905184, 201905185, 201905186, 201905187, 201905189, 201905190, 201905191, 201905192, 201905193, 201905194, 201905195, 201905196, 201905180 due to same reporter.  Follow up received from other health professional on 22-Oct-2019: Classification 'Special case with no AE' removed. Anatomical location for vaccination added in product tab. New event added. No revaccination. Narrative amended accordingly.  Follow up received from other health professional via agency (reference number: SEQ19-06241) on 06-Nov-2019: Start date of event provided. Narrative amended accordingly.  Company comment: The patient experienced vaccination site erythema after incorrect route of the suspect product Afluria Quadrivalent administration. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Incorrect route of product administration is assessed as not related per company's conventions. Causality between suspect product and the event vaccination site erythema is assessed as possibly related.; Sender's Comments: The patient experienced vaccination site erythema after incorrect route of the suspect product Afluria Quadrivalent administration. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Incorrect route of product administration is assessed as not related per company's conventions. Causality between suspect product and the event vaccination site erythema is assessed as possibly related.
administer  expired vaccine to 450 patients, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer  expired vaccine to 450 patients, after the manufacture date of expiration.) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer  expired vaccine to 450 patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer  expired vaccine to 450 patients, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 102 doses. Expiration date was reported as 24-Oct-2021.  Dates of administration of vaccine were reported as 25, 26, 27 and 29-Oct-2021.  The vial did not undergo any temperature excursions.  No treatment information was provided.   This case was linked to MOD-2022-585570, MOD-2022-585570, MOD-2022-585708, MOD-2022-585713, MOD-2022-585645, MOD-2022-585650 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2022: Significant follow-up recieved, Reporter information updated and additional reporter added, patient information added, product date of administration was updated. I narrative updated. On 08-Jun-2022: Follow-up recieved contains non-significant information
102 fever, extreme nausea and vomiting, body aches, headache, fatigue Nausea and vomiting stopped after approximately 12 hours, concurrent with my taking anti-nausea medication emetrol. Other symptoms slowly improved and were gone by Sunday May 2.
This spontaneous report was received from a Licensed Vocational Nurse and refers to a 18 year old male patient. Patient's concurrent condition, medical history and concomitant medications were not provided. On 09-SEP-2015, the patient was vaccinated the first dose of GARDASIL (dose, administration route, lot #, expiration date and anatomical site were not reported). On 04-NOV-2015 the patient was vaccinated with the second dose of GARDASIL (dose, administration route, lot #, expiration date and anatomical site were not reported). On 05-JAN-2016 the patient was vaccinated with the third dose of GARDASIL lot # L037003, expiry date 25-MAY-2017 (dose, administration route and anatomical site were not reported). No adverse effects were reported. It was unknown if the patient sought medical attention. No product quality complaint (PQC) was involved. This is one of two reports received from the same source. Additional information has been requested.
Swollen lymph under left arm; Headache; Body ache; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8727), via an unspecified route of administration in left arm on 25Mar2021 at 17:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included that the patient was diagnosed with COVID-19. Concomitant medications included vitamin b12 (MANUFACTURER UNKNOWN), vitamin d (MANUFACTURER UNKNOWN) and calcium (MANUFACTURER UNKNOWN). The patient was allergic to morphine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since having the vaccine, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced swollen lymph under her left arm where the vaccine was received and also experienced headache and body ache. The patient had not received any treatment measure for the reported events. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of swollen lymph, headache and body ache was unknown at the time of this report.  No follow-up attempts possible. No further information expected.
Client reported she became woozy after returning home. C/O post nasal drip, runny nose, feeling "washed out", off and on yellow phlegm. No fever.
2 cm induration, 1 cm erythema.  Treated with warm compress, Augmentin.  Recheck in 5 days.
I had a routine PSA exam that was elevated. I was referred to a urologist who performed a biopsy. The results did come back showing prostate cancer. I have started my cancer treatment and feel that my survival is good.
Blood clot (DVT) in right leg; pulmonary embolism (multiple blood clots in lungs); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 11Aug2021 (Lot number: EWO198) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: WARFARIN. Vaccination history included: Bnt162b2 (First dose, Batch/Lot Number: EYO584), administration date: 21Jul2021, when the patient was 46 years old, for Covid-19 Immunisation. The following information was reported: DEEP VEIN THROMBOSIS (hospitalization, disability, medically significant, life threatening) with onset 11Aug2021, outcome "not recovered", described as "Blood clot (DVT) in right leg"; PULMONARY EMBOLISM (hospitalization, disability, medically significant, life threatening) with onset 11Aug2021, outcome "not recovered", described as "pulmonary embolism (multiple blood clots in lungs)". The patient was hospitalized for deep vein thrombosis, pulmonary embolism (hospitalization duration: 1 day(s)). The events "blood clot (dvt) in right leg" and "pulmonary embolism (multiple blood clots in lungs)" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Nov2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of deep vein thrombosis, pulmonary embolism and treatment included blood thinners. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Chills, fatigue, and very tender and swollen arm-started 1 1/2 days after IZ -> treated with ice, PERCOCET.
This is a spontaneous report from a contactable physician's assistant. A 61-year-old male patient of an unspecified race/ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on 20Jul2017 for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Jul2017, the patient experienced arm pain at injection site, severe restriction of joint range of motion, muscle pain. The outcome of the events was unknown.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, an unspecified number of patients were vaccinated with PNEUMOVAX 23 (route, dose, lot # and expiration date were not reported). It was reported that PNEUMOVAX 23 was improperly stored and the temperature excursion was found to be supported with in-house stability data. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Approximately 15 minutes after receiving, DTAP, MMR, and IPV vaccines child exhibited allergic response, edema to bilateral orbital areas. Administerd 10cc Prelone orally, 10 minutes later 10cc Benadryl oral, and 10 minutes later 0.1mg adrenaline chloride subQ.  Pt was observed for 1hr, edema was reduced, given Rx's to continue Benadryl and Prelone oral therapy, and advised to go to ER if symptoms return.  Pt was asked to follow up at Clinic on 8/8/03 but did not return.
Pt developed dizzyness - increased upon standing-postural changes . Drank water and observed for 40 minutes w/o improvementVS
GOT COVID; This spontaneous report received from a consumer concerned a female of unspecified age. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced got covid. The action taken with covid-19 vaccine was not applicable. The outcome of got covid was not reported. This report was non-serious. This report was associated with product quality complaint 90000206891. Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
an 18-year-old gentleman with a past medical history significant for perimembranous ventricular septal defect and severe aortic valve insufficiency, status post ASD and VSD and aortic valvuloplasty  back in 2004.  He had repeated surgical aortic valvuloplasty with moderate residual aortic valve insufficiency.  He is followed closely by the pediatric cardiology service.  On his last office visit on 1/7/2020, there were concerns regarding increased BMI, elevated systolic blood pressure, and wide pulse pressure.  Need for repeat aortic valve surgery was addressed during the visit.  The cardiac MRI was done in March of 2021 which revealed worsening to severe aortic insufficiency with an increasing left ventricular dilation with a reduced EF of approximately 60% and reduced right ventricular ejection fraction of 66% from previous studies.  The patient was COVID positive in February 2021.  He received the second COVID vaccine back on 6/10/2021.  The patient presented to Emergency Department on 6/12 at approximately 12:30 in the afternoon complaining of shortness of breath, cough as well as nausea and vomiting for approximately 1 week.  He had chest pain and fatigue that had been worsening over the last 48 hours. No fevers. No sick contacts.    A CT angiogram of the chest was obtained which was negative for PE.  After return from that study, a nurse found the patient in severe respiratory distress.  The patient became bradycardic and profoundly hypotensive and then subsequently went into a PEA cardiac arrest at approximately 4:30 p.m. on the 12th.  CPR was initiated.  He was intubated and subsequently placed on venoarterial ECMO  at 1719 that day by the cardiac surgery service.  Post ECMO, the patient's mental status was questionable after the arrest.  He was noted to have rightward gaze by the emergency department physician.  A transthoracic echo was performed at 1815 which demonstrated wide open aortic insufficiency with flail segment.  He was transferred to us as a tertiary care center and escalation of care.  The patient was admitted to the Heart and Vascular ICU team in the adult cardiothoracic surgery service.  Upon arrival to the ICU, the ECMO circuit was changed from a Novalung to the CentriMag ECMO circuit.
Dizziness, bad headaches, severe soreness in arm, blurred vision, drowsiness.
Arm extremely sore - had difficulty putting on and taking off t-shirts/sweatshirts - could not lift arm up totally.  I don't remember when exactly the fever started, but it last until the 36th hour after the vaccination.  It was 101.3 most of the time.  101.7 was the high point.  I also had stomach pain at that time.  After 3 days I was fine.  With the 1st shot I also had a sore arm, but not this bad.  I also ran a fever, but it was around 100 then.