chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of INJURY (Felt like she got hit by a mack truck, it was rough), LIMB DISCOMFORT (Problems with her legs/legs feel very heavy), PAIN IN EXTREMITY (Legs are very sore) and ORTHOSTATIC HYPOTENSION (Head rushes) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter.  Concomitant products included TRAZODONE, QUETIAPINE FUMARATE (SEROQUEL), BUSPIRONE HYDROCHLORIDE (BUSPAR), BUPROPION HYDROCHLORIDE (WELLBUTRIN), HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]) and CLONIDINE for an unknown indication. On 29-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced LIMB DISCOMFORT (Problems with her legs/legs feel very heavy) and PAIN IN EXTREMITY (Legs are very sore). On 29-May-2021, the patient experienced INJURY (Felt like she got hit by a mack truck, it was rough). On an unknown date, the patient experienced ORTHOSTATIC HYPOTENSION (Head rushes). In May 2021, INJURY (Felt like she got hit by a mack truck, it was rough) had resolved. At the time of the report, LIMB DISCOMFORT (Problems with her legs/legs feel very heavy), PAIN IN EXTREMITY (Legs are very sore) and ORTHOSTATIC HYPOTENSION (Head rushes) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment medication was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Full body hives starting about 10 days after Moderna booster shot (all 3 shots were Moderna). Treated with 20mg prednisone for 10 days in conjunction with 10mg Zyrtec 2x daily. After 10 days of Prednisone, started 10 days of 10mg Cimetidine while still taking Zyrtec. Continued daily use of 10mg Zyrtec 2x daily after Cimetidine was out. Hives reduced to skin rash while taking Zyrtec but returns to hives once stopping Zyrtec. While medicated, the skin rash shows up randomly all over the body but disappears within 10-15 minutes. Rash can be brought on by simply touching the skin- for example, if I get scratched, the scratch marks will show up 5 minutes later and last for 15. Seems to almost manifest like a delayed reaction skin sensitivity but without feeling the rash itself (I.e. doesn?t burn or itch) while medicated. Without medication it manifests as hives.
Case was hospitalized for COvid 7 months after the J and J vaccine.    * COVID-19 Assessment & Plan Sxs started 11 days prior to admission ~ 9/26/21 Vaccinated with J and J vaccine covid neg x 3 last week and covid + on 10-3-21   Treated with 4 days of Decadron and Remdesivir and this was stopped on discharge as he no longer had any oxygen needs and has hyperglycemic on the Decadron    It is not clear if he had active covid but given that he had new oxygen needs and recently converted covid to + on the 3rd I felt it was reasonable to treat him while in the hospital    CRP was 6 on admission then rose to 8.5 on the 9th and by the day of discharged was down to 1.44 This dose not need to be followed once discharged LFTs remained stable on the Remdesivir        Community acquired pneumonia of right upper lobe of lung Assessment & Plan He denies a history of aspiration but has a lobar right upper lobe infiltrate with air bronchograms.   This could be a post viral bacterial pneumonia   He got 4 days of Rocephin and completed the Zithromax during his stay and will discharge on Augmentin for 6 more days   Would advise getting a repeat chest x-ray in approximately 2 to 3 weeks to assure clearance of the RUL infiltrate and then repeat CT scan in a couple of months to make certain that the infiltrate has completely resolved and there is no underlying pathology.   Sputum culture c/w upper airway flora
Puffy eyes, lips, itching on body, closing of throat.                 (Anaphylactic type symptoms. ) Swelling at injection site. Extreme  fatigue and aches over 6 days later.
Edema, erythema, tenderness at left deltoid x 1 day. No fevers/ fluctuation/ 0/C. Treated with warm compresses and Augmentin.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 16-NOV-2015 the patient was vaccinated with oral ROTATEQ (lot # L008057, expiration date 01-DEC-2016, oral, dose not reported), which was exposed to temperatures outside of the recommended temperature (incorrect product storage). No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of CHLAMYDIA TEST POSITIVE (Vaccine caused chlamydia\positive chlamydia test) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 01ZAZ1A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced CHLAMYDIA TEST POSITIVE (Vaccine caused chlamydia\positive chlamydia test) (seriousness criterion medically significant). At the time of the report, CHLAMYDIA TEST POSITIVE (Vaccine caused chlamydia\positive chlamydia test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Chlamydia test: positive (Positive) positive.         Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided.  Company Comment: This case concerns a 29-year-old female with a serious unexpected event of Chlamydia test positive. Event onset with unknown latency after first dose mRNA-1273. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 29-year-old female with a serious unexpected event of Chlamydia test positive. Event onset with unknown latency after first dose mRNA-1273. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Muscle pain both arms, back, neck, left leg starting 2 days after immunization.
pt recv varicella vax in 12/95 & in 4/98 pt exp chickenpox w/approx 20 lesions.
Pt had swelling of (L) side of neck that started about day 4 after MMR, Tmax 101.2 swelling is tender, decreased ROM of neck rest of exam unremarkable.
Case number PHEH2014US022376, is an initial spontaneous report from a nurse received on 04 Nov 2014. This report refers to a 19-year-old female patient. Medical history and concomitant medications were not reported. The patient received an intramuscular dose of Men A lyophilized component of MENVEO (batch number: M14069) that was erroneously reconstituted with a sterile water instead of Men CYW-135 liquid component on 01 Nov 2014. No adverse event reported following this medication error.
Vaccinator reports she was injecting vaccine into child's left arm when the child moved and more than half the vaccine dribbled down left arm. Re-vaccinated child in right arm successfully.
Patient given expired Pfizer. Bottle transferred from freezer to fridge on 2/10/2022. Expired 03/13/2022. Vaccine given on day 34 after transferred to Fridge. Per call with Pfizer, dose does not need to be repeated as vial is considered stabile x 45 days after transfer.
LEG PAIN, LACK OF APPETITE WEIGHT LOSS, RASH, SPENT 3 DAYS IN BED, NO ENERGY.
Sore throat, cough began. Cough got worse and fever began slowly on 11/21/09, fever of 101 to 102 for two days through 11/23/09- cough continued through 11/24/09.
day 2 sore arm tingling fingers restless sleep. day 3 sore arm tingling fingers  cotton mouth. day 4 tingling fingers cotton mouth. day 5 soreness under the arm hard to put arm all the way down to my side cotton mouth tingling fingers. day 6 tingling fingers soreness worse under the arm radiating up over the shoulder
Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 16-APR-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 23-JUL-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
pt recvd vax; 6nov-8nov viral pertussis; to er; exanthem 9:15pm;fever 100.9;rash;generalized adenopathy;wheezing/asthma;
48 hours after vaccination, patient developed right sided facial droop, excessive tearing in right eye, inability to close right eye fully, inability to raise right eyebrow. Patient advised to not take 2nd vaccine dose. He was given oral corticosteroid prescription and advised to use eye lubrication ointment frequently and wear eye patch at night. He was advised to see Ophthalmologist to make sure no injury to cornea since he is unable to fully close eye and potential for eye drying at night when sleeping.
I felt like a ''hook'' going to my soul and something is killing me; Something is stealing my soul from me; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) 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: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "I felt like a ''hook'' going to my soul and something is killing me"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Something is stealing my soul from me"Consumer stated, "Hey, so, I took the vaccine and I have some really bad side effects.Reason for no lot number: of Covid-19 Vaccine was reported as Caller unwilling to complete the report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Localized reaction, red area about 2 inches, warm to touch noticed by mother on 12/13/11 in evening vaccine administered 12/12/11. Child denies pain or itching. Treatment with Hydroxyzine syrup and cold compress.
07/01/2005 next morning, water blisters broke out both arms from elbows to upper arms where shots given, next day spread to forehead, cheeks and behind knees very itchy. On 07/02/2005 mother called doctor and was prescribed Zyrtex to dry up rash. Was seen by Dr. week of 07/04/2005, rash drying and fading.
This spontaneous case reported by a consumer, describes the occurrence of tenderness (tenderness on arm), erythema (redness) and feeling hot in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. October 2021, patient received the third (booster) dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced  tenderness (tenderness on arm), erythema (redness) and feeling hot. At the time of the report,  tenderness (tenderness on arm), erythema (redness) and feeling hot outcome: unknown. No concomitant medications or treatment information provided. The patient wanted to figure out whether to put ice on it. Reporter did not allow further contact.
2 pts were inadvertently given intradermal DTP instead of PPD,p/3 days,1 pt had no problems;2nd pt devel inflamed erythematous area,turned bluish,"almost eccymotic",15cm in size;regional lymph nodes swollen as in the arm,paresthesias in arm
Patient states on night of 10/24/19 she started feeling very cold and then very hot. Temperature maximum of 99.7 degrees F. Also felt like her heart was racing. Increased gastric reflux symptoms. Felt very tired and fatigued all weekend. Went to the doctor on Friday. Had the chills again on Saturday and noticed her urine was very dark gold colored.  Symptoms began resolving on Sunday 10/27/19 and is feeling better today, 10/28/19. Prescribed Carafate on 10/25/19 for gastric refulx symptoms.
A non-serious spontaneous report of "inadvertent administration of expired H1N1 LAIV" was received from a non-healthcare professional concerning a child of an unknown gender. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 25-Feb-2010. In mid March-2010, the patient received expired H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Fever >102.0 F for 7 hours Starting at 19:30  19Jan2021 Fever 100-101.5 F for 29hrs starting 02:30 20Jan2021 End date 05:30 21Jan2021  Muscle aches and bone pain start19:30,  19Jan2021  resolved  23:00 20Jan2021  Severe headache starting at 19:30  19Jan2021 resolved 11:00,  21Jan2021 mild cough starting at 19:30  19Jan2021  resolved 01:00 22Jan2021-   Only treatment for all symptoms was rest and oral hydration
as mentioned before nauseous, vomiting, back pain, weak,  body ache , menstral cycle started earlier then it was supposed to.
no adverse event; A patient was administered 1 dose of improperly stored ROTATEQ; This spontaneous report was received from a nurse concerning a 4 month old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions or drug reactions/allergies.    On 02-OCT-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 1 dose, orally, lot number R015435, expiration date 17-APR-2020  to prevent rotavirus gastroenteritis (prophylaxis) (product storage error). The administered dose of the vaccine experienced a temperature excursion of 9.1C for 19 minutes, as recorded by a data logger. There was no adverse effect reported.
Within 12 hrs; redness, swelling, fever, body aches. Lasted 48 hrs; red/swelling about 5 days.
I developed a severe intensely itchy rash on my left arm. It spread to my right arm about two weeks later. Nothing over the counter helped. I tried ice and it helped calm down the itching some.  I have been to my regular doctor who prescribed cortisone shots and creams. That did not work. I finally went to a dermatologist who diagnosed me with eczema and she has been trying different things but so far nothing has stopped the itching. The medications I have tried are very expensive and I am disabled. The itching keeps me awake at night and it is very difficult if not impossible to get a good night's sleep. I am not able to do most things that I did before I got the eczema.
Hypertension, unstable heart rhythm, atrial fibrilation, shortness of breath, cough, jaw pain, joint pain, skin rash, insomnia, loss of muscle mass, malaise, insomnia, treated w/SOTALOL, inhalants, steroids, nsaids, TEVETEN, symptoms still persist.  12/19/2008 MR received for DOS 10/16-17/2008 with D/C DX:  COPD/asthma exacerbation.  A-fib, converted to NSR.  HTN.  Psoriasis.  GERD. Pt presented with c/o R sided chest pain following several week hx of cough/SOB and low grade fever. Found to be in A-fib and wheezing on admission. Converted to NSR with Betapace. Tx with nebs, anti-inflammatories and steroids with improvement. Cardiac consult with dx:  URI.  Pleuritic chest pain.   12/26/08 Office note from PCP recd for DOS 10/1/08. Pt c/o joint pain, malaise decreased appetite, insomnia and blotches. Asessment:  Immune response vs drug reaction./  02/01/2010 Follow-up: Following the Innoculations symptoms continued. In August of 2009 I was diagnosed with Lyme disease. There is some doubt about which symptoms result from Lyme and/or innoculation.
pt recvd vax & exp malaise & myalgia; w/in 24 hrs of vax pt exp chills w/fever, fatigue, nausea, malaise, & myalgia; w/in 48 hrs pt devel sinusitis that lasted for 1 wk;
pt recv vax;devel multi sclerosis;f/u info stated: MD had no more info regarding pt;
painful arthritis in my right hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but unknown manufacturer), for COVID-19 immunization. The following information was reported: ARTHRITIS (non-serious), outcome "not recovered", described as "painful arthritis in my right hand".  Additional information: It was reported that side effects of final Pfizer booster gave the patient painful arthritis in their right hand that remained daily.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt tested positive for COVID 3/30/2021, planned procedure needed to be rescheduled
shingles; Information has been received regarding a case in litigation from a lawyer and the pt on 02-OCT-2020, referring to a 70 year old pt of unknown gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On an unknown date in April 2018, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot# and route unknown) for prophylaxis. The pt suffered the following injuries as a result of the zoster vaccine live (ZOSTAVAX) vaccine: shingles on 02-OCT-2018, reported as permanent and lasting in nature. The outcome of shingles was reported as not resolved. The causality assessment between shingles with zoster vaccine live (ZOSTAVAX) was reported as related. The adverse event of shingles was considered a disabled event.
This case was reported by a healthcare professional and described the occurrence of flu like symptoms in a 25-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 19 April 2011 the subject received 1st dose of HAVRIX (unknown, left arm). On 19 April 2011, 2 hours after vaccination with HAVRIX, the subject experienced flu like symptoms. On 19 April 2011, the subject also experienced excessive sleep (slept for 18 hours). On 26 April 2011, flu like symptoms improved. At the time of reporting, excessive sleep was improved.
administered / an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA371A, expiry date 31st July 2021) for prophylaxis.   On 18th August 2021, the patient received Menveo. On 18th August 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The lab assistant called to report that, nurse from  their facility administered an expired dose of Menveo, which led to expired vaccine used. No data available from patient. The reporter consented to follow up.
I contracted Covid 19; I contracted Covid 19; 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 72-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 25Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I contracted Covid 19". The patient underwent the following laboratory tests and procedures: Prostatic specific antigen: High/Go up, notes: show high PSA levels/every time I got a vaccine or a booster, my PSA readings go up. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical Course: It was also reported that patient had 2 vaccines and 2 boosters and then the paxlovid, every time he got a vaccine or a booster, his PSA readings go up because he contracted Covid 19, he have a chart. He taken the vaccine and when got back his PSA readings back and every time I got a vaccine or a booster, my PSA readings go up. He took Paxlovid as well. He wanted to know if there is correlations between Paxlovid and Pfizer Covid-19 Vaccine with his PSA increase. He took Paxlovid took 2 months ago, on 12Aug2022 also read in case studies that if you contract covid, that also elevates the PSA, there's a test, 91 people PSA levels went from 1.58 to 4.34 on average.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
3 days later difficult to awaken while on a trip; when awakened had a high pitched cry which took 15" or more to stop; no localizled rxn; no temp has hx of ear infect; 9APR92 devel black gums in areas, cultured strep throat; diarrhea;
Had a fever of 102 day and day after injection.  Than I work up with redness on stomach,  neck,arms and hands.  I forgot to mention that I do have next plan on implanted in my left arm.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Information regarding the patient's medical history, concurrent conditions or concomitant medication was not reported. On an unknown date, the patients were vaccinated with improperly stored (OKA/MERCK) VARIVAX injection (dose, frequency, route and lot number were not provided). No adverse events were reported. Additional information has been requested.
Large local swelling at site of injection of Anthrax vaccine (5th in series) that extended from shoulder to mid-upper arm, warm, tender and red.  Swelling resolved after 7 days.
Headaches, chills, feeling of fever, joint pain, and muscle pain.  Symptoms lasted for about 24h. Pregnant, 3 weeks by the time of vaccine. 29/1/2022 All symptoms were relieved with paracetamol every 6hours
Local swelling and redness. Hardened area approximately 5 mm x 10 mm. Granuloma formation approximately 1 week post vaccination.
pt given flu vax @ 12noon;@ 430PM pt exp dull achy pain lt shoulder w/softball sized lump @ inj site;c/o chest pressure & mild itchiness all over, worsened over 6hr;went to ER @ 11PM;
On Dec. 5, 2006 seizure lasting approx 20-40 secs at home. Took by squad to hospital. Seizures again at 7pm, 10pm and 4am on Dec. 6, 2006. Phenobarb given at hospital at 10pm. 1 more dose given then no more seizure activity. Currently on Phenobarb 3cc BID PO.  2/6/07 Received medical records from hospital which reveal patient experienced apnea spells with circumoral cyanosis & leftward gaze.  Parents took patient to ambulatory care center when had another spell.  Currently had cold s/s & cough & has been fussy.  Tx w/IV antibiotics & was admitted for monitoring.   FINAL DX: Acute life threatening episode & questionable seizures.
Pt received hep B vaccine. Left and went to lobby with mother and passed out. She hit her head on the floor when she fell. 137/81 P 71 3:40pm, 127/84 P 93 3:50pm, 119/79 P 99 4:05. Went to private MD to check knot on her head.