chrisvoncsefalvay/vaers-outcomes huggingface dataset:
That is my supercharged out to kill anything that comes near me, overreactive immune system going to be; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  An adult female 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: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "That is my supercharged out to kill anything that comes near me, overreactive immune system going to be".  Additional Information: Batch/Lot number unknown. The patient's relevant medical history and concomitant medications were not reported. Causality: Related. I just want to wait and see because I saw people who flew through, you know, the flu vaccine, hadn't had a problem with their Hep B series. They got this vaccine and the immune response that it generated was pretty profound. And they were pretty, like, knocked down.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The first shot i was sick about 8 hours after and recovered.... However the second shot i was extremely sick for 24-36 hours after. Severe fever, chills, stomach sickness, body aches, and strange chest pain... I almost went to the hospital because I was scared.  I didn't know this existed or i would have reported it sooner.
Child's arm appear swollen, red and blotchy from shoulder to elbow. Dr treated with Zyrtec. Mom reports she gave pt Zyrtec for 3 days, swelling and redness were gone after 2 days.
Ceased and regressed in all developmental milestones including speech, walking, toilet training and showed obvious signs of lacking simple comprehension. Advised by healthcare provider that original records of 2nd dose administration were lost and that receiving a third posed no risk to the child.
patient developed purpuric rash all over body consistent with vasculitis, and severe joint pain and swelling, nausea, vomiting, diarrhea, Fever
pt recv vax & 1-2hr post vax pt exp prophylaxis w/SOB, facial & chest tightening & facial & chest flushing; ER or MD visit was required;
Lump the size of a Lime under the right armpit.; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the right arm on 04May2021 at 09:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medicines within two weeks prior to the vaccination. On 05May2021 at 20:00, the patient noticed a lump, the size of a lime under the right armpit. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lump, the size of a lime under the right armpit was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Breakthrough case admission after 3 vaccines ; Moderna 3/1/21 Lot# 010A21A;  Moderna 3/29/21 Lot# 018B21A;  Moderna 1/17/22 Lot# 084J21A
COVID-19 vaccine 3rd dose; Chills; Fever; Body aches; Blurred vision; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose: 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "COVID-19 vaccine 3rd dose"; CHILLS (non-serious), outcome "unknown", described as "Chills"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; PAIN (non-serious), outcome "unknown", described as "Body aches"; VISION BLURRED (non-serious), outcome "unknown", described as "Blurred vision". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
have a hard time breathing; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date (at the age of 72 years age) (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Verbatim and Event Description: Patient called stated doctor office having problem calling in refill and wanted to know if can call in herself because "I'm out of it and I really need it." Also on call patient asked "I got my shots for the covid 19 was one of the side effects have a hard time breathing. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient is a 70 Y male who presents to the local Emergency Department complaining of left toe problem to be admitted for surgery by podiatry.  Patient has COVID but denies any COVID symptoms.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 05-SEP-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2016, the patient was treated for persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
pt devel palpable, purpuric lesions over lower extremities; also exp pain in the proximal interphalangeal joints of the lt 2nd & 3rd digits unassoc w/swelling or erythema; skin biopsy of one purpuric lesion revealed focal areas of necrosis
SEVERE, INTENSE CONTINUAL BODY ACHES THAT LASTED FOR UP TO 2 WKS.  I THEN DEVELOPED PAIN AND WEAKNESS IN MY HIPS, THIGHS THAT HAVE LASTED TO THIS DAY.  I HAVE MUSCLE WEAKNESS IN MY THIGHS AND I'M UNABLE TO WALK, CLIMB OR DESCEND STAIRS OR STAND WITHOUT SEVERE PAIN.  I WILL SOMETIMES EXPERIENCE NUMBNESS IN MY LEGS IF I STAND TOO LONG.   I DID NOT HAVE THESE SYMPTOMS PRIOR TO THE SECOND DOSE OF THE MODERNA VACCINE.
Rashes/itching - all over body 5 days after vaccine given SOLU-MEDROL shot one time and BENADRYL pill as needed.
miserable; aching on her joints; headache; chills; fever of 101.2F; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (miserable), ARTHRALGIA (aching on her joints), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever of 101.2F) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 011A21A and 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021 at 5:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced FEELING ABNORMAL (miserable), ARTHRALGIA (aching on her joints), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever of 101.2F). At the time of the report, FEELING ABNORMAL (miserable), ARTHRALGIA (aching on her joints), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever of 101.2F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2021, Body temperature: 101.2 (High) 101.2F.         No relevant concomitant medications were reported. Treatment information was unknown.
Contracted Covid; Contracted Covid; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 50-year-old male patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: El3247), on 23Feb2021 as dose 2, single (Lot number: EL3247) and on 22Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Jun2022, outcome "recovering" and all described as "Contracted Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Jun2022) Positive, notes: Covid test type post vaccination= Unknown. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: It was unknown if Covid prior vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information
FULLY VAXED AS OF 2/24/2021 AND DEVELOPED COVID SXS 9/10/2021 AND DIAGNOSED 09/12/2021. ADMITTED TO HOSPITAL 9/15/2021 DUE TO COVID.CURRENTLY STILL HOSPITALIZED, IMPROVING AND HAS PLANS FOR BEIGN DISCHARGED TO REHAB WITHIN THE WEEK
This spontaneous report as received from a other health professional refers to a 15 year old female patient. On 31-JUL-2017 the patient was vaccinated with GARDASIL 9, intramuscular for prophylaxis. On 2017 the patient experienced injection site pain and nervousness. The outcome of nervousness and injection site pain is unknown. {Additional information has been requested. Additional information is not expected.}
Information has been received from a licensed practical nurse, for GARDASIL, a Pregnancy Registry product, concerning a 23 year old female patient who in June 2008, was vaccinated with the first dose of GARDASIL (lot#, route and site of administration not reported) and she was not given any other doses of GARDASIL because she was pregnant. Unspecified medical attention was sought. In August 2009, the patient delivered a healthy baby via C-section. Upon internal review, delivered a baby via C-section was determined to be an other important medical event. No further information is available since the office nurse reported that they did not deliver the patient's baby.
PASSED OUT, PATIENT RESPONDED SHORTLY AFTER,  PATIENT WAS ABLE TO LEAVE UNDER HIS OWN POWER
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided.  In approximately 2016 (since 08-FEB-2016), the patients were vaccinated with improperly stored doses of M-M-R II (lot # L020189, expiration date 03-JUN-2017; lot # L026551, expiration date 16-JUL-2017, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 9 degree Celsius for 9 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Admitted to the hospital with multiple small strokes; Feeling fatigue; Headache; A spontaneous report was received from a consumer concerning a 79-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced being admitted to the hospital for multiple small strokes, fatigue and headache.  The patient's medical history was not included. Products known to have been used by the patient were not provided.  On 21 Jan 2021, prior to the onset of the events, the patient received the first of planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.    On an unknown date, Shortly after the mRNA-1273 vaccine was given, the patient experienced fatigue and headache which was attributed to vaccine side effect. On 27 Jan 2021, the patient was admitted to the hospital with multiple small strokes.  No other treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, fatigue, headache and being hospitalized with multiple small strokes, is unknown.; Reporter's Comments: This case concerns a 79 year-old, female patient, who experienced events of multiple small strokes, fatigue and headache. The events of fatigue and headache occurred on an unknown date after the first and last dose of mRNA-1273 vaccine administration. The event of stroke occurred approximately 6 days after the first and last dose of mRNA-1273 vaccine administration.  Based on the current available limited information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
pt recvd vax 8SEP93 & devel a sudden onset of pilaris type keratosis w/ a rough feeling rash on both arms which persisted for 8-9 days;
chills; fatigue; headache; 102 fever; The initial case was missing the following minimum criteria: This case has been considered invalid as unspecified adverse event. Upon receipt of follow-up information on 02Mar2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient (also age at vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), the second dose via an unspecified route of administration, administered in Arm Left on 06Feb2021 1:30 PM (Batch/Lot Number: CL1964) as SINGLE DOSE for covid-19 immunization. Medical history included chronic respiratory disorder (Fumes/vapour), Chronic rhinosinusitis (Sinus surgery) from 07Jan2021, Observance sleep apnea from 16Sep2019 (CPAP machine), and Sinus condition for years from unspecified date; all unknown if ongoing. For the sinus condition for years a surgery was needed and was recommended between 1st & 2nd vaccine shots (on 04Feb2021) and the surgery were planned prior to taking the vaccine. The types of surgery recommended were septoplasty, functional endoscopic and turbinectomy. The patient also had family history which includes Heart diseases and High blood pressure from unknown date and unknown if ongoing. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at 52-years-old at the time of vaccination Lot: EL3247 administered in Arm Left on 16Jan2021-1:30 PM for Covid 19- immunization and experienced GERD on 17Jan2021 (Pertinent Details: Endoscopy). Concomitant medication included cefuroxime axetil (CEFUROXIME AXETIL ZHIJUN, 500mg tab) taken for an unspecified indication from 08Feb2021 to 16Feb2021; oxycodone hydrochloride, paracetamol (OXYCODONE AND ACETAMINOPHEN, 5-325) taken for an unspecified indication from 05Feb2021 to 05Feb2021 (also reported as (Only one tab). The patient experienced 102 Fever, chill (reported onset from last dose was 7 minutes), fatigue, Headache on 06Feb2021. The patient was not admitted hospital due to the events.  The outcome of the events was recovered on 07Feb2021. No Treatment were received.   Information about lot/batch number has been requested.
Had yearly check-up. Fine-no problems. Got PREVNAR shot. 2 wk. later sick. Thought nothing to be concerned about. Kept getting sicker. Dr. diagnosed pneumonia 6-4-15.
pain in left arm, after 10 days.....bad cough , head cold, touch of pnuemomia.
feeling like he has a cold like he's been outside; Fever; Congestion with running nose; Congestion with running nose/nose is running; This is a spontaneous report from a contactable consumer (patient) reported for himself. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch / Lot Number: not reported, Expiry date, NDC: Not Provided), via an unspecified route of administration on 31Jul2021 as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date in 2021. the patient feels like he had a cold like he's been outside. On an unspecified date in 2021 complaints of fever and congestion with running nose. The patient was asking if these side effects are normal with the administration of the Pfizer Covid-19 vaccine. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Chills, fever (104), body ache Fever lowered to 102 with tylenol by 8am fever was below 100, body aches were minimal and chills were gone. Fatigue throughout following day 101.5 Fever returned around 6pm on 3/11 - lowered to below 100 with tylenol after night's rest, no symptoms from then on
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 18Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), first regimen from 12Mar2021 (Lot number: 001B21A) to 12Mar2021 at single (dose 1, single) and second regimen from 09Apr2021 (Lot number: 030B21A) to 09Apr2021 at single (dose 2, single) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VALACYCLOVIR HCL taken for covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (unspecified date) positive; (11May2022) Negative; (13May2022) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Shingles on left front side of abdomen.Previously, I had received 3 doses of the Pfizer covid vaccine. The 4th vaccine was the first time I had received the Moderna vaccine.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  HYPOXIA  3/24/2022  --  RECURRENCE OF SAME SYMPTOMS
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: 5 minutes after vaccine was given, patient complained of blurry vision, lightheadedness, dizziness and L arm tingling and weakness extending to the digits. Resolved within 10 minutes after oral fluids and feet elevation. No lingering effects >2 hours after this event.
headache; joint and muscle pain; joint and muscle pain; Nausea; A canker sore on the side of the tongue; A spontaneous report was received from a consumer (patient type) concerning a patient (unknown gender) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event, Patient received first dose of Moderna Covid-19 vaccine on 22Jan2021 at 11:00 AM. On that night patient experienced headache, joint and muscle pain and nausea. Also, a canker sore on the side of the tongue was mentioned following the vaccination.    The patient's medical history were unknown.   Relevant concomitant medication include Clonazepam since an unknown date for unknown indication .   on 22Jan2021 at 11:00 AM prior to the onset of the events, the patient received their mRNA-1273 (lot/batch: 013L20A) unknown route for prophylaxis of COVID-19 infection.    On 22Jan2021  On that night patient experienced the event headache, joint and muscle pain and nausea. Also, a canker sore on the side of the tongue following the vaccination on Left arm. Facility of vaccination: Lot number: 013L20A. Expiration date is Not provided.Patient was angry and jealous because husband did not experienced any of these symptoms   Laboratory details was not provided.     Patient reports to take Advil and Tylenol for treatmen .  Action taken with mRNA-1273 in response to the events was not reported.      The outcome of all reported events were recovered/resolved on 25JAN2021 The reporter assessment for the event(s) headache, joint and muscle pain and nausea and canker sore were not provided.
Initially developed redness and swelling within 24 hrs of injection and then developed atrophy and necrosis at site.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got shingle. The patient stated he/she year received shingle vaccine and two weeks ago gotten shingles again. Not as full blown, but none the less got shingle. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.