chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 13 year old female with no previous medical history or no known drug allergies, who in April 2008, was vaccinated IM in the left arm with a 0.5 ml first dose of GARDASIL (lot# 658094/0524U).  There was no concomitant medication.  For the first week after the vaccination the patient would develop a "bruised area" at the injection site after someone touches or hits the area.  Unknown medical attention was sought via telephone.  The bruising resolved one week after the injection.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 06/13/2008. Initial and follow up information has been recieved form a physicain concerning a 13 year old female with no previous medical history or no known drug allergies, who on 14-Apr-2008 (also reported as April 2008)m was vaccinated intramuscularly in the left deltoid with a 0.5 ml first dose of GARDASIL (lot # 658094/0524U). There was no concomitant medication. On 14-Apr-2008 (also reported as for the first week after the vaccination) the patient developed several areas of brusing all over her body not just at the injection site and "red bumps that may have been potechiac". Also reported as "bruised area" at the injection site after someone touches or hits the area. Unknown medical attention was sought via telephone. The bruising and red bumps resolved after one week. On 16-Jun-2008, the patient had a CBC, PT and PTT performed which were all within normal limits. A previous CBC performed 04-Apr-2008 was also within normal limits. Additional information is not expected.
Patient presented for a 1st dose of Moderna vaccine and while being monitored in post-vaccination observation, began hyperventilating. She reported dizziness and anxiety. Onsite EMTs were called for support. Patient was helped to lie down on cot by EMTs. Patient began to feel better and was helped to sit in a chair by EMTs. Patient called a rideshare to get her home rather than driving. EMTs approved patient departure from clinic.
Now I have a tendency to have an erratic heartbeat; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE IRREGULAR (Now I have a tendency to have an erratic heartbeat) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced HEART RATE IRREGULAR (Now I have a tendency to have an erratic heartbeat). At the time of the report, HEART RATE IRREGULAR (Now I have a tendency to have an erratic heartbeat) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included blood thinners.  Reporter stated that, this time had a terrible reaction and previously did not have a terrible reaction. Patient did not have any such bad reaction for any of the other shots she had or during the shot. Patient had a tendency to have an erratic heartbeat. Patient did experience this after a shot. Patient had been taking all Moderna and mentioned this was her fifth shot and this time had a terrible reaction with it.  No treatment information was provided.   Reporter did not allow further contact
Pt developed acute weakness and pain in both legs prompting admission to hospital 10/25/15 - 11/6/15 MRI brain normal.
Arm is red, painful and swollen going down the arm.  Feels like she has a bump under her elbow.
Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit; Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 6:08 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.  It was reported that the vaccine was at frozen storage condition at the time of the temperature excursion. Excursion duration was 1 month.  On 19-Nov-2021, the Moderna COVID-19 vaccine vial went from the super cold freezer to the refrigerator. The vaccine was returned to the freezer/refrigerator/ultra cold freezer, or maintained at room temperature.  No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened.  The patient was given doses from a vial that were stored in an ultracold freezer which is colder than they should have been.   This case was linked to MOD-2021-402935 (Patient Link).
Erythematous area measuring 15 1/2 x 12 1/2 cm L deltoid region - vaccine given 1/5/2010.  Sxs occurred 1/7/2010.  Patient seen in office upon advise if reaction.  Patient informed to take IBP (OTC) for discomfort.  Apply cold pack 10-15 min every hour; elevate arm at heart level.
Pt has a 10x10 mm lump under a bruised area left lateral aspect thigh, very hard. Mom did use cold compress or ice bag to area. Immunization given 3/5/04 was for Pediarix.
Increased tinnitus, light red rash around injection site both shot 1 & 2, muscle soreness in shot arm, unable to move shot arm properly without pain for over a week
Redness, swelling, deltoid - area (left) of shot. Pain, blisters varying sizes shot site. Patient sent to ER, secondary VARIVAX (given left arm) treated with steroids.
Initial soreness x 3 days then: 12/29/20:  itchy with a lump present, 12/30/30: worsening symptoms, redness measures 4cm x 2cm and the induration is 5 cm x 5cm, warm. No fever
Yesterday about 5 hours after receiving the vaccine I started to feel a tingling numbness down my whole left  arm down to my fingertips. I assumed it was related to the soreness of the injection site but then I started feeling it down my right arm as well. The sensation has persisted for over 18 hours straight.
Soreness on her upper shoulder; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was wondering why her mother did not experience any reaction after getting the first dose of COVID-19 vaccine today unlike her. After getting the COVID-19 vaccine on an unspecified date, the patient experienced a reaction which was soreness on her upper shoulder for a couple of days. The patient recovered from the event on an unspecified date.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Blisters when busted they oozed yellow liquid; Itchy; Scabs; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6205) via an unspecified route of administration in the left arm on 09Mar2021 at 14:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient received unspecified concomitant medication within two weeks of vaccination. The patient had no allergies to medications, food, or other products. 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 13Mar2021, on the fourth day after receiving the vaccine, the patient experienced blisters which when busted oozed yellow liquid, was very itchy and the patient had 5 on right foot, one near left elbow and one in back of throat. Even after a month the patient still had scabs. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with prescription antihistamine and steroid cream. The clinical outcome of the event blisters with oozed yellow liquid and itchy on right foot, left elbow and back of throat and scabs was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Hospitalized 8.30.21;  COVID-19 positive 8.31.21; fully vaccinated  Admission Date: 8/30/2021 Discharge Date: 09/06/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Pneumonia of both lungs due to Pseudomonas species, unspecified part of lung [J15.1] Pseudomonal pneumonia [J15.1] Bronchiectasis [J47.9]   HOSPITAL COURSE: Patient is a 74 y.o. who has a past medical history significant for long-standing severe bronchiectasis of unclear etiology, heart failure with reduced ejection (NICM) complicated by severe aortic stenosis (for which she is currently undergoing evaluation for TAVR), atrial flutter on chronic Eliquis, and chronic anemia. She was admitted 8/30 for presumed exacerbation of her chronic bronchiectasis, with recent sputum cx having grown multi-drug resistant Pseudomonas aeruginosa. Historically, she has hx of isolation of multiple morphotypes of Pseudomonas, as well as hx of Burkholderia and Citrobacter in the past. She was admitted on the recommendation of her primary pulmonologist. She had failed 2 rounds of ciprofloxacin this month and was still having increased sputum production, cough. She grew pseudomonas again 8/19 but was resistant to oral agents. She was started initially on meropenem but after beign seen by ID was transitioned to ceftazidime which she tolerated well. CT thorax showed new foci of patchy and nodular infiltrates. Film array incidentally returned positive with COVID-19. She did have ongoing hemoptysis but NOT massive and was controlled. SHe was seen by pulmonology and ID throughout her course. Hemoptysis improved and stabilized. She was back to her baseline 2L O2. ID recommended continuing ceftaz through 9/14. SHe had a midline placed on 9/6 and was discharged home in stable condition with home visiting nurses and infusion setup to start at 1700 today. Her eliquis was resumed and she was told to monitor for further hemoptysis. PCP was messaged to have their staff set up a follow up appointment, even if virtual.   ROS Patient feels good today. Ready to go home. Excited to get home. No new symptoms. Coughing improving slowly. No further significant hemoptysis. No fevers no chills. Breathing easier.    CONSULTS / RECOMMENDATION: pulm ID INPATIENT PROCEDURES: Midline placed 09/06/2021
Patient states she went to take off the spot band aid from the injection on 4/24/18 in the shower 0700 and noticed her right arm at the injection site was hot to the touch, red, raised at injection site, and itchy. 4/25/18 Patient had shown the injection site to me and it was red and size was 2x2 on right arm.  Patient will observe and if worsens will be seen by a provider.
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 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14May2022 at 13:00 as dose 4 (booster), single (Lot number: FMO173) at the age of 69 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: BENADRYL, start date: 15Jul2022, stop date: 20Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jul2022) Negative; (25Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Anti viral Paxlovid treatment from 15Jul2022 to 19Jul2022).  Clinical course: Patient received other medication within 2 weeks. Patient does not have any known allergy. Anti viral details: Product: COVID 19 Treatment, brand: Pfizer, treatment start date: 15Jul2022, treatment stop date: 19Jul2022.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (arm is a little bit sore) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. No medical history reported. January 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. February 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 26, 2021, patient received the third (booster) dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 26, 2021, patient experienced pain in extremity (arm is a little bit sore). At the time of the report, pain in extremity (arm is a little bit sore) resolved. No concomitant medication or treatment information reported. Reportedly, patient also had some blood in urine after booster dose.
Felt quite fatigued and had a persistent noticeable headache for over 24 hours that did not go away with Alleve.  Then, I noticed a pink rash all over my abdomen after a shower that was about 54 hours later.  It may've been there the day before, but I felt so bad, I went to bed early and did not look at my abdomen during that first day.  I could've missed it the first day because it was not bright red.  The rash was slightly raised, mildly itchy.  The rash was gone about 10 hours after I noticed it.
Butterfly Glioblastoma/Stage 4,terminal cancer; first dose on 04Mar2021, second dose on 04Mar2021; This is a spontaneous report from a contactable consumer (the patient). A 69-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in right arm on 04Mar2021 14:00 (Lot Number: EN6203), dose 2 via an unspecified route of administration in right arm on 04Mar2021 (Lot Number: EP6955), both at age of 69-year-old at single dose for COVID-19 immunisation. The patient had no medical history. No known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, the patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 01Jul2021, the patient was diagnosed (after MRI) with a butterfly Glioblastoma. Her physician estimated that the tumor was 3 months old, which was completely time coincident with receipt of the Pfizer vaccine! This was Stage 4, terminal cancer. The event "butterfly glioblastoma/stage 4,terminal cancer" onset date was 01Apr2021. The event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 3 days, Life threatening illness (immediate risk of death from the event). Treatment for the event included radiation and chemotherapy. The outcome of event "butterfly glioblastoma/stage 4,terminal cancer" was not recovered.
After vaccines I get hotflashes all day and night. My temperature has remained normal; This is a spontaneous report from a Non-contactable Other-HCP (patient). A 56-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number EH9899, via an unspecified route of administration from 21Dec2020 16:00 to 21Dec2020 16:00 (at the age of 56-years-old) as a single dose in the right arm, for COVID-19 vaccination. The patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration from 11Jan2021 as a single dose in the right arm lot number EK9231, for COVID-19 vaccination.  Medical history included autoimmune illnesses from an unknown date and unknown if ongoing , many allergies from an unknown date and unknown if ongoing , occasional hot flashes (before vaccines I got only occasional hot flashes) from an unknown date and unknown if ongoing Before vaccines I got only occasional hot flashes.  There were no concomitant medications.  The patient was administered the vaccine in hospital.  The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced before vaccines she got only occasional hot flashes. After vaccines she got hot flashes all day and night on 22Dec2020. Her temperature has remained normal. No treatment was received for the event. The patient underwent lab tests and procedures which included temperature: remained normal on 22Dec2020. 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 clinical outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
I had my shot around 10:45 am, was fine my arm hurt, hard when you touched it. In the middle of the night I was freezing cold, headache, heat coming off my body, no temp, everything ache and hurt like I was hit by a truck. I called out of work and slept all day. I only got up to use the bathroom and get a drink. I feel tired today 1/22/21 but chills, hot, aches are all gone. It lasted like 24 hours.
presented with covid symptoms; +covid in ED; admitted with Covid PNA & PE; tx with supplemental O2, maxipime, steroids, actemra, Vit D, Zinc,
5/12/21 04:00 awoke with nosebleed, blood blisters on face and abdomen (all new) 5/12/21 afternoon arrived to hospital with gum bleeding in addition to symptoms above. Initial platelets = 2 and q6h CBCs yielded PLTs of 0. 0, 1, and 1 in first 24h.  CBC & BMP otherwise WNL. Treatment for acute idiopathic thrombocytopenia was initiated by hematology/oncology. Patient refused blood products including IVIG on religious grounds.  Within 24 hours, he  started IV dexamethasone, oral  tranexamic acid  subcutaneous romiplostim (Nplate). Bleeding controlled within first 2 days but oral ulcers remained.  Strict bedrest to avoid injury. Uneventful hospital course. Bone marrow biopsy on 5/25/21.
shingles - I went to doctor after two weeks of side effects from shot and she confirmed it was shingles, but it was too late for the medication to work.
Bacteremia w/pos blood culture for Hemophilus influenza type B, buccal cellulitis; pt had one wk of upper resp sx & fever;
I did not clarify if the patient had shingles before the COVID Vaccine; This is a spontaneous report from a contactable pharmacist via a Pfizer sponsored program. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The pharmacist had a patient did the COVID vaccine the previous day and was being prescribed Valtrex (treatment) for shingles. The pharmacist clarified the patient has not started the Valtrex yet, but the pharmacist did not clarify if the patient had shingles before the COVID Vaccine. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL on 25-MAY-2011, and with the second dose on 27-NOV-2012 (doses, routes, lot numbers not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Injection site reaction / Bad rash; Injection site / red; Injection site / raised; Injection site / warm to the touch; Injection site / very tender; This case was reported by a physician via sales rep and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st July 2020, the patient received the 1st dose of Shingrix. In July 2020, less than a day after receiving Shingrix, the patient experienced injection site rash, injection site erythema, injection site swelling, injection site warmth and injection site tenderness. On an unknown date, the outcome of the injection site rash, injection site erythema, injection site swelling, injection site warmth and injection site tenderness were not recovered/not resolved.   It was unknown if the reporter considered the injection site rash, injection site erythema, injection site swelling, injection site warmth and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient was given Shingrix dose and experienced injection site reaction.  The physician stated there was a really bad rash that was abnormally large, red, raised and warm to the touch and very tender. The physician stated she has never seen this bad of a reaction like this to a vaccine.  It was reported that It had been 2 days since she was administered the vaccine. The patient has not had an injection site reaction like this before with other vaccines.
Information was received from a medical assistant regarding a 14-year-old male who received a dose of GARDASIL 9 on 19-AUG-2015 (lot # L019287, expiration 14-SEP-2017) and a second dose of GARDASIL 9 on 01-DEC-2016 (lot # M016193 expiration 24-APR-2018) which is outside of the indication per prescribing information. Concomitant medications and medical history were not reported. No adverse effect was reported. Additional information has been requested.