chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red bumps two weeks after receiving each of the Moderna shots and continued to break out for a couple of months after the second shot; itchy bumpstwo weeks after receiving each of the Moderna shots and continued to break out for a couple of months after the second shot; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH ERYTHEMATOUS (red bumps two weeks after receiving each of the Moderna shots and continued to break out for a couple of months after the second shot) and RASH PRURITIC (itchy bumpstwo weeks after receiving each of the Moderna shots and continued to break out for a couple of months after the second shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (red bumps two weeks after receiving each of the Moderna shots and continued to break out for a couple of months after the second shot) and RASH PRURITIC (itchy bumpstwo weeks after receiving each of the Moderna shots and continued to break out for a couple of months after the second shot). At the time of the report, RASH ERYTHEMATOUS (red bumps two weeks after receiving each of the Moderna shots and continued to break out for a couple of months after the second shot) and RASH PRURITIC (itchy bumpstwo weeks after receiving each of the Moderna shots and continued to break out for a couple of months after the second shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.   This case was linked to MOD-2022-446893 (Patient Link).
Left foot swelled up and painful Next day swollen and discolored A week later still the same and went to see PCP He didn?t seem alarmed but here I am out 2 weeks and altho not as swollen it still is swollen and discolored from middle of toes to just below ankle
Information has been received from a health professional concerning an approx 2.5 year old female who in approx June 2004, was vaccinated SC with a dose of varicella virus vaccine live. On 09Dec05 it was reported that the pt recently developed a vesicular rash that involved one of her eyes. Unspecified medical attention was sought. There was no product quality complaint involved. Vesicular rash was considered to be an other important medical event (OMIC). Additional information has been requested.
Pt stated he did not receive the Janssen vaccine. So nurse administered 2nd dose of Pfizer. Hospital Director completed additional follow up & verified pt did receive 1dose of J & J & 2 doses of Pfizer vaccine.
CELLULITIC RASH LEFT FOREARM APPROX 3.5 CM X 2.5 CM PATIENT ALSO REPORTS RASH TO NECK, HEADACHE AND SORE THROAT.
Mild fever, achiness, (Rt) arm - swollen, painful, hot to touch.
painful; Shingles/an outbreak of shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On 29th January 2020, less than 2 years after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced pain. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the pain was unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported.  The patient received Shingrix at least a year and couple of months ago in an unknown arm, but the reporter assumed left arm. The reporter could not remember vaccination facility information during call. Consumer intends to receive 2nd dose after forgetting about it. During call, consumer mentioned 2 days ago she started having an outbreak of shingles and mentioned she may not be able to receive 2nd dose at this time. Caller described shingles course as becoming worse and being in a little bit of arc. After probing, caller defines that as the feeling when shingles is about to start and then shingles becoming painful. No further description of outbreak provided. The reporter consented to follow up. Consumer consented to HCP follow-up but mentioned her physician at her clinic recently retired and she does not know who new provider was yet. Agreed to follow-up.
Immediate severe headache lasting 8 hours.  Lips and tongue had very mild/slight swelling for 4+ hours. Fingers felt swollen but nothing visually for 6 hours.
Information has been received from a physician concerning an approximately 10 weeks old female with no pertinent medical history and no drug reactions/allergies, who on 01-OCT-2007 was vaccinated po with a first dose of Rotateq. There was no concomitant medication. The physician is reporting that the patient was admitted in the hospital for dehydration. On approximately 03-OCT-2007 or 04-OCT-2007, two to three days after administration of the dose of Rotateq, the patient experienced fever, vomiting, and diarrhea. The patient tested positive for rotavirus antigens. Lab diagnostics studies performed included: electrolytes- abnormal (unknown date). The patient was treated with IV fluids for dehydration. The patient is currently in the hospital. The outcome is reported as recovering. No further information was available. The events were considered other medical event by the reporter. There was no product quality complaint. Additional information has been requested.
Child large red duration to left deltoid as stated by mother. Cellulitis to arm. Follow up on 06/24/04 states: "The time and date of onset is unknown as written in on the form. The health department was contacted prior to submitting the form. They did not have specific information. It was sometime between 09/22/03 when the vaccine was administered and 09/26/03 when it was reported."
Patient started with vomiting on 9-10-13 at 1430 and was seen in provider office at 1540 and had diarrhea also. Followed up 9-11-13 at 0915 with improved vomiting but heme (+) diarrhea in office.
Patient developed fever and chills, had cold hands all of Friday night and then on Saturday the injection site was swollen with purple bruising.  Currently the whole arm is tender and patient has itching at injection site.
Pt recv vax on 5/11/98; 1.5 hr post vax pt exp tight chest x 45 min; tx=Benadryl & Tagamet
Red spots began to appear on legs, in time spread to 90% of my body, red, rash, itchy legions/spots.
Lost energy, head spins, tird all the time. Failed stress test, quad pupils surgury. Lost 3 months income (17500)     225,000 dollar surgury,    Is this long term effect. Sent email a couple time in the last 3 weeks
Chills, body aches, headache, nausea started about 10 hours after vaccine administered. Most symptoms lasted 30 hours. Nausea lasted a few days.
Patient vaccinated at 11:50am. Patient reported itchy throat at 12:10pm. Patient administered Benadryl 25mg. Also given juice and granola bar. Patient reported improvement 10 minutes later. Patient vitals remained within normal limits. Patient observed for 30 minutes. Patient released following reported symptoms diminished. Patient instructed to go to ED for further evaluation if throat swelling occurs after leaving clinic.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 10:16 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 10:16 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.     Concomitant products were not provided.  On 13-Feb-2021, Excursion time was 09 AM, temperature was 32, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  On 13-Feb-2021, no hourly temperature recordings available.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Hives; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Apr2021 at 13:45 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history included elevated cholesterol. The patient had known allergies to fish and seafood. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 15:30 the patient experienced hives and nausea. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event hives and nausea was resolving.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
10/22/21 visit to ER with due to confusion and inablity to form sentences thought he was having a stroke, unable to respond was sent home after several hours and told to come back if happens again. 10/23/21 back to ER, was admitted to ICU - 10 L O2,  bloodclots in ULQ of lung, stayed in ICU 5 days then ICU stepdown 8 days, then to rehab for 10 days now receives rehab at home.
78 y/o female ( pt) with PMH of BLLE lymphedema, chronic wounds, and recurrent cellulitis.  She presents s/p falls x2 last night with increased illness, increased lower extremity pain, redness, swelling,  and worsening purulence  despite being on oral bactrim and keflex since 1/18/22.  She was last admitted here in Sept 2021 w/  b/l lower extremity cellulitis (no bacteremia) and treated with IV cefazolin with improvement.  No wound cx avail  from that visit but records show  prev  cultures were positive for PSAR,  +Corynebacterium striatum and have been periodic dating back to 2019. The patient notes she is seen by Dr in the wound clinic and also Dr  has followed and treated her with both oral an antibx and IV courses at the facility.  She denies previous surgical interventions such as debridements and has had no recent hospitalizations elsewhere.  She notes she has been quite weak the last few days, and had #2 falls last night where she just collapses.   She stated no LOC. She c/o's acute on chronic Left hip/buttock pain and is restless on stretcher.   She has had intermittent chills, no fevers, no n/v/d and has been eating normally, no urinary symptoms (other than chronic incontinence-wearing diaper), she is voiding, no ShOB, no CP, no syncope, no palpitations  but reports a chronic productive cough  --she keeps expectorating pale tan phlegm in room-- no hemoptysis; c/o thirst   Mild nausea, no diarrhea, no abd pain.  She is constipated--last BM 34 days ago. In the ER  she is afebrile.  BPs on higher side,  HRs stable in NSR on monitor; no respiratory distress.   NCCT Head: no  acute IC abnormality;  there is acute sinus dis.  pCXR and Left hip/pelvic XR pndg--note has h/o severe OA with avascular necrosis possibly noted in past.     Her labs show leukocytosis to 19K, left shift,  PCT elevated @ 1.42, hgb 8.8 (from 9.3 in Dec).  Sodium 127,  K+ 6 (4.8 in Dec), Cl 93, bicarb 18, no gap, BUN/creat 149/3.4 (73/1.5 in Dec),  CK pndg, gluc 119,lactate 1.4, COVID -19 positive (was known positive 1/13/22 --asymptomatic though chronic cough).  WC ordered  1/17/22 Outpt WC obtained by Dr positive for GBS, light PSAR (pansensitive), light MRSA w/ MDRO. She meets sepsis criteria w/ qSOFA of 2..  She received 500 cc of IV NS in ED --will cont w NS @ 125cc/h, and started on IV vanco, cefepime, & LVQ.   Hospital Medicine has been asked to admit the patient.    PT IS INPATIENT AT THIS TIME.
pt recvd vax 26JUL95 & AUG95 lab eval revealed that pt serum varicella antibody was again neg;No further details were provided;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 26Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 10Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 27Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "Sinus problems from allergies" (unspecified if ongoing); "Sinus problems from allergies" (unspecified if ongoing); "Known allergies: Sulfa antibiotics" (unspecified if ongoing). Concomitant medication(s) included: AMOXICILIN, start date: 11Jul2022, stop date: 20Jul2022; MONTELUKAST, stop date: Aug2022; SYMBICORT, start date: Mar2014, stop date: Aug2022. Past drug history included: Codeine, reaction(s): "Drug allergy".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jul2022) Positive; (30Jul2022) Negative; (02Aug2022) Negative; (03Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient tested positive for COVID on 25Jul2022 and started Paxlovid that day. Took it for 5 days, had two negative tests on 30Jul2022 and 02Aug2022. Symptoms recurred and stronger on 03Aug2022 and tested positive-rebound case. The patient received no other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Batch/Lot number: unknown), on 20Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 20Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "mildly elevated LFTs (ALT 59, AST 44)" (unspecified if ongoing); "ALT 59" (unspecified if ongoing); "AST 44" (unspecified if ongoing); "self reported hx fatty liver" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with oral Paxlovid from 20Jul2023 to 22Jul2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy (vaccination failure and COVID-19) with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
SCAR TISSUE OVER RETINA IN RIGHT EYE; MUSCLE ACHES FROM SECOND MODERNA VACCINE; MUSCLE ACHES FROM BOOSTER MODERNA VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of RETINAL SCAR (SCAR TISSUE OVER RETINA IN RIGHT EYE), MYALGIA (MUSCLE ACHES FROM BOOSTER MODERNA VACCINE) and MYALGIA (MUSCLE ACHES FROM SECOND MODERNA VACCINE) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Panuveitis.    No Medical History information was reported.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) UNK - Ongoi. In June 2021, the patient experienced MYALGIA (MUSCLE ACHES FROM BOOSTER MODERNA VACCINE). In December 2021, the patient experienced MYALGIA (MUSCLE ACHES FROM SECOND MODERNA VACCINE). On an unknown date, the patient experienced RETINAL SCAR (SCAR TISSUE OVER RETINA IN RIGHT EYE). At the time of the report, RETINAL SCAR (SCAR TISSUE OVER RETINA IN RIGHT EYE) had not resolved and MYALGIA (MUSCLE ACHES FROM BOOSTER MODERNA VACCINE) and MYALGIA (MUSCLE ACHES FROM SECOND MODERNA VACCINE) outcome was unknown.            No concomitant products were reported.  On an unknown date, the patient experienced scar tissue over retina in right eye. In June 2021, the patient experienced muscle aches from second moderna vaccine. In December 2021, the patient experienced muscle aches from booster moderna vaccine. moderna covid-19 vaccine (elasomeran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. On 20-May-2021, patient received 1st dose covid-19 vaccine manufactured by moderna. On 20-Jun-2021, patient received 2nd dose covid-19 vaccine manufactured by moderna. On 08-Dec-2021, patient received booster dose covid-19 vaccine manufactured by moderna.  Causality for humira (adalimumab) The reporter's causality for the event(s) of scar tissue over retina in right eye with humira(adalimumab) was a reasonable possibility. the reporter's causality for the event(s) of muscle aches from second moderna vaccine and muscle aches from booster moderna vaccine with humira(adalimumab) was no reasonable possibility.  No treatment information was reported by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
This spontaneous report as received from a medical assistant regarding unspecified number of patients (ages and genders not provided). Sometime in JUN-2017 the patients were vaccinated with VARIVAX lot # M033211 exp 13-JUL-2018 and lot # N002204 exp 19-JAN-2019, PROQUAD lot# M037011 exp 21-APR-2018 and lot# M044719 exp 07-MAY-2018, and sterile diluent(STERILE DILUENT). It was reported that the products were stored improperly. The sterile diluent was stored properly. PROQUAD and VARIVAX were stored at 6F to 14F for 14 hours and 7 minutes. No previous temperature excursion. Data logger was yes. There were not reported symptoms. Additional information has been requested.
Approx. 1 week after my first dose, the injection site began to swell, became hot to the touch, and painful. I could not lay on that side of my body. It started with a nickel size red spot and by the end of the day had progressed to a softball size red circle. My lymph nodes were swollen on both sides of my body. My underarms itched. My left shoulder near the injection site became painful and sore. This lasted for approx. three days before subsiding.
I have a 102.2 temp; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (I have a 102.2 temp) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced PYREXIA (I have a 102.2 temp). At the time of the report, PYREXIA (I have a 102.2 temp) outcome was unknown.            No concomitant medication was reported. The treatment information was not given.   Action taken with m-RNA-1273 in response to the event was not applicable.   Reporter did not allow further contact
pt recv vax & 30-45min p/vax pt was taken to ER for diff breathing & urticaria given Solumedrol, Pred, DPH, Epi in ER d/c home same day;
pt recv vax 11APR96 & 3wk into tx/sertraline, WBC was nl;25APR96 2wk post vax pt devel neutropenia & was hosp;
Bell's Palsy on right face seen in ED 1/18/21 - ear pain, facial droop, eye lid droop, drooling, headache
Reports temp 100 at 7 pm 2/29/08. Woke up 3/1/08 5 am - temp 102 unk duration. Headache 5 AM with sx lasting off/on until 11:00 AM 3/1/08. (Stuffy nose 5 am 3/1/08 - 8 or 9 am), sore throat 5 am 3/1/08 until 3/2/08 8 or 9am. Went to hospital 3/1/08 at 11 am or 12 pm and dx with "throat virus". Antibiotics given (unk names) t bid - finished 2/6/08. Temp 100 3/4/08. Temp 99.9 3/4/08. Temp 99 3/2/208.
Temp, chills, right arm sore after vaccine, body aches, and head ache
On 05/18/2022 I had a cough but by the next day my cough was getting worse and I was getting chest pain when I coughed. I also felt feverish, hot and had chills. I took a home test on 05/20/2022 and it was positive. I had a telehealth appointment on 05/20/2022 and was prescribed Paxlovid and I started it that day. My symptoms started to decline after 2 days of taking my medication and I am having no symptoms as of today.
minor difficulty, breathing   spo2 was 100 on RA.  pt was advised if she started to have more problems breathing to call 911 or her doctor
PT received Kinrix, Proquad 4/25/19, that night patient c\o pain and mother noticed warmth and swelling  on right arm where vaccines where administered. Pt was taken to Urgent care, was prescribed benadryl and ibuprofen