chrisvoncsefalvay/vaers-outcomes huggingface dataset:
'blotchy bruised rash' (Petetchae like) in the lower leg from the knee to the bottom of the foot, scattered; The baby did try to pull her leg, but she may have some pain from the injection; 'blotchy bruised rash' (Petetchae like) in the lower leg from the knee to the bottom of the foot, scattered; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team.  An 11-week-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 28Jul2022 as dose 1, single (Lot number: FG5300, Expiration Date: Apr2024) at the age of 11 weeks, in left thigh for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pentacel, for Immunization; Hep b, for Immunization. The following information was reported: VACCINATION SITE BRUISING (non-serious), VACCINATION SITE RASH (non-serious) all with onset 29Jul2022, outcome "unknown" and all described as "'blotchy bruised rash' (Petetchae like) in the lower leg from the knee to the bottom of the foot, scattered"; VACCINATION SITE PAIN (non-serious) with onset 29Jul2022, outcome "unknown", described as "The baby did try to pull her leg, but she may have some pain from the injection". The events "'blotchy bruised rash' (petetchae like) in the lower leg from the knee to the bottom of the foot, scattered" and "the baby did try to pull her leg, but she may have some pain from the injection" required physician office visit.  Additional information: The physician said it was a blotchy bruised rash on leg from her knee down to the bottom of her foot. The presentation of the rash is scattered. She doesn't think it is serious. The child was acting herself. She was able to hold the baby's foot on the table. The baby did try to pull her leg, but she may have some pain from the injection. The baby has full range of movement. It doesn't look deep. The parents didn't mention anything on 28Jul2022. The parents noticed in the morning of 29Jul2022 and sent the doctor a picture. The event did not require an emergency room visit. The doctor had the patient come in. This was her 2 months shots, and first time getting this vaccine. The doctor spaces her vaccines out, so the infant received Pentacel and Hep B two weeks ago. Causality: it is hard to tell if the vaccine caused the rash. It is likely related because it is in the same leg, and the same lower part of leg. There is no other explanation. The parents denied the leg getting caught on anything or something like that. The bruise was very local. It wasn't scattered bruising or she would have done blood work. There were no other rashes.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 14 years old adolescent patient and unknown gender. On 14-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Pt vaccinated w/1st dose of vax w/o adverse experience; following 2nd dose rheumatoid arthritis flared up;
Nausea and nasal congestion by 45 minutes; Nausea and nasal congestion by 45 minutes; Hives on face by 30 minutes; Forehead and eyelids swelled in about 15 minutes; Forehead and eyelids swelled in about 15 minutes; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 09:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, chronic obstructive pulmonary disease (COPD), allergies (unspecified), arthritis, gastroesophageal reflux disease (GERD), hypertension and IV X-ray contrast allergy. 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. Concomitant medications included montelukast (MANUFACTURER UNKNOWN), budesonide, formoterol fumarate (SYMBICORT), ipratropium bromide (ATROVENT), Hydrochlo (MANUFACTURER UNKNOWN) and salbutamol (ALBUTEROL); all were taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received thimerosal (MANUFACTURER UNKNOWN), leuprorelin acetate (LUPRON), ceftriaxone sodium (ROCEPHIN), amoxicillin (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. On 31Mar2021 at 09:30, about 15 minutes after the vaccination, the patient experienced forehead and eyelids swelled; at 09:45, by 30 minutes after the vaccination, the patient experienced hives on face; at 10:00, by 45 minutes after the vaccination, the patient experienced nausea and nasal congestion. The events 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events forehead and eyelids swelled in about 15 minutes, hives on face by 30 minutes and nausea and nasal congestion by 45 minutes was resolved on an unknown date in Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Left arm edema, erythema, tenderness (all left arm) no forearm BENADRYL and cold compresses. TYLENOL or Ibuprofen for pain.
fever; chills; His arm also swelled so badly that it looked like he had an extra muscle; This is a spontaneous report received from a contactable other healthcare professional. A male patient of an unspecified age received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), 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 patient experienced fever, chills and his arm also swelled so badly that it looked like he had an extra muscle on an unspecified date after use of the vaccine. The outcome of the events was unknown.   No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Had COVID 3 weeks ago; Had COVID 3 weeks ago; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) 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 "Had COVID 3 weeks ago". Clinical course: Caller stated she has taken 3 Pfizer COVID-19 vaccines, the primary series and a booster. She wanted to know if she can get the bivalent booster even if she had COVID 3 weeks ago.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
ZOSTAVAX was administered 10-05-10. Patient called 10-7-10 had circular about 4" rash around injection site. Patient called 10-8-10 rash larger about 8"
Right arm swelling--2 inch diameter increase of entire arm. Warm to touch. Monday, tender from treatment. Prelone 15mg/5ml 1 tsp B10 for one week. Zithromax 200ml/5ml, 1 tsp day one, 1/2 tsp day 2-5.
Shoulder pain for more than 7 weeks with no improvement. I will probably enter into a course of physical theraphy
Complained of dizziness, watery eyes, runny nose, and weakness shortly after receiving her second dose of Pfizer. She \ requested to lie down and was escorted to a stretcher. She was provided   oral loratidine with slight improvement of symptoms. Approximately 30 minutes after her inoculation her status had not worsened but she requested to be taken to the emergency department. Rapid Response team was notified and assisted her to the ED.
This spontaneous report was received from a doctor of pharmacy referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of M-M-R II (strength, dose, route, anatomical location, lot number and expiration date were not provided), for prophylaxis (reported as "vaccines"). On an unknown date, the patient had an anaphylactic reaction an unspecified amount of time after vaccine administration. It was unknown if the patient received any treatment.     At the time of reporting, the outcome of anaphylactic reaction was unknown. The causal relationship between the event and the M-M-R II was not reported. Upon internal review, the anaphylactic reaction was determined to be a medically significant event.
got vax 13th woke up short of breath with 101 fever, headache, then had to use the bathroom every 20 minutes (urinate only). symptoms lasted about 48 hours. Only has 1 kidney due to renal carcinoma and doesn't want 2nd shot he is afraid to damage his only kidney and if side effects are worse the second time he doesn't want that.
Sore arm the whole arm was bruised and hurt to even touch this lasted a week and a half . My face around my eyes were swollen and red and puffy and sore that lasted a week and a half. My throat was tight and a little hard to breathe lasted a day or two. Has servers body aches and the pain in my shoulder still persist to this day. Fever 100.3 two-3 days.
mental fogginess; Always tired; shortness of breath (waking in middle of the night unable to catch breath); bad anxiety with problems sleeping; problems sleeping; vision not as clear; dizziness; irregular ekg; This is a spontaneous report from a non-contactable consumer (patient). A 57-year-old female patient (not pregnant) received the second dose of BNT162B2 via an unspecified route of administration on the left arm on 09Apr2021 at 10:00 AM (Lot Number: EW0150) at the age of 57-year-old as single dose for COVID-19 immunization. Medical history included asthma, type 2 diabetes, IBS & Gerd and psoriasis. known allergy included Codeine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient perform nasal swab on 03Aug2021 and result was negative. The patient didn't received other vaccine within 4 weeks prior to the COVID vaccine. Concomitant medication included sitagliptin phosphate (JANUVIA), fluticasone propionate (FLOVENT), ramipril and alprazolam (XANAX). The patient previously received codeine and experienced allergy. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 19Mar2021 at 10:00 AM (Lot Number: EN6207) at the age of 57-year-old as single dose for COVID-19 immunization and no events reported. On 15Apr2021 at 10:00, the patient experienced always tired, shortness of breath (waking in middle of the night unable to catch breath), bad anxiety with problems sleeping, mental fogginess, vision not as clear, dizziness, and irregular ekg. Treatment was unknown whether received. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
My mother got a pneumonia vaccine and died of pneumonia.; My mother got a pneumonia vaccine and died ofpneumonia.; This is a spontaneous report from a contactable consumer (patient's son/daughter) from a Pfizer Sponsored Program Comscore DTC Ad Testing with Pricing Language.   A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration at single dose on an unspecified date for immunisation.   The patient medical history and concomitant medications were not reported.  The patient got a pneumonia vaccine on an unspecified date and died of pneumonia on an unspecified date.  It was not reported if an autopsy was performed.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Pneumonia
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 09-APR-2014 the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # J009723, expiry date 30-JAN-2015), 0.5 ml, intramuscular. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Vision was becoming narrow; very nauseous; Heart started beating very fast; Muscles twitching especially tongue into the back of throat; Feeling faint; This is a spontaneous report from a contactable other healthcare professional, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8736) via an unspecified route of administration in the left arm on an unknown date in May2021 at 10:15 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Patient had no medical and past drug history. Patient did not receive any other medications within 2 weeks of vaccination. 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 an unknown date in May2021, within 2 minutes after the vaccination, she started feeling faint and her vision was becoming narrow. The patient also felt very nauseous and her heart started beating very fast. After about 30 minutes of the vaccination, she started to feel her muscles twitching, especially her tongue into the back of her throat. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether the patient was received any treatments. The clinical outcome of the events feeling faint, vision was becoming narrow, very nauseous, heart started beating very fast and muscles twitching and was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient details (updated), Events detail (Treatment Received updated as unknown).
Immediately following the shot and for 24 hours after I had numbness/stiffness/pain on the left side of my body from my head to my foot. Since the shot I have had left knee pain that has not subsided.
after 5 mins patient receiving the shot, she fainted on the chair at the pharmacy waiting area.  Immunizing pharmacist injected patient epipen shot and she woke up afterward. Paramedic was called.
No additional AE or PQC reported.; MMR II that expired on 11MAY2022 was administered to a patient on 27JUN2022; This spontaneous report was received from a medical assistant referring to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent conditions, concomitant medication, drug reactions, or allergies was not reported.   On 27-JUN-2022, the patient was vaccinated with the expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant Human albumin (rHA) (lot # T016198, and expiration date: 11-MAY-2022) (Expired product administered) (strength, dose, unit, and route of administration were not provided) for prophylaxis. The vaccine never had any temperature excursions.   No additional adverse event (AE) or product quality complaint (PQC) was reported. No additional information was provided.
48 hrs. post Varicella #2 vaccine pt developed swelling, redness in (L) upper arm, site of vaccination.
Left side of my face swollen up. Left Jaw muscle swollen. Last one day, full recovery on second day.
Pounding headache Feeling like my jaw and throat were locking up Heart pounding and increased heart rate Tremors worse than normal Chills Swelling at site of shot
Husband had the shot still got them /Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Husband had the shot still got them /Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-JUL-2023 This case was reported by a patient wife via interactive digital media. The reporter reported that her husband received Shingles vaccine still experienced shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Child received the 2nd second dose of hepatitis A vaccine before the minimum interval.  The 2nd dose of MMR and Varicella were administered before the 4th birthday.
pt began to turn red in face and arms and chin. Had itching on chin. Gave patient 50mg benadryl ...waited 30 minutes and started feeling better. Daughter arrived to take her home as she was drowsy.
Achy/ Pain; Stiff leg; Passing Gas; Breathing not normal; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy/ Pain), MUSCULOSKELETAL STIFFNESS (Stiff leg), FLATULENCE (Passing Gas) and RESPIRATION ABNORMAL (Breathing not normal) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03CQOA) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included RIVAROXABAN (XARELTO) for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Achy/ Pain), MUSCULOSKELETAL STIFFNESS (Stiff leg), FLATULENCE (Passing Gas) and RESPIRATION ABNORMAL (Breathing not normal). At the time of the report, PAIN (Achy/ Pain), MUSCULOSKELETAL STIFFNESS (Stiff leg), FLATULENCE (Passing Gas) and RESPIRATION ABNORMAL (Breathing not normal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Parson's Turner Syndrome, numbness and pain in brachial plexus right side.
This case was considered medically important. Information regarding PREVENAR was received from a healthcare professional regarding a male patient who experienced frequent pneumococcal infections. The patient received the fourth dose in 2007. The patient experienced frequent pneumococcal infections. Outcome was unknown. No additional information was available at the time of this report.
Severe debilitating pain in left hip joint beginning 7 days after vaccine. Worsening daily. Healthy fit person prior to this. Worked out regularly. No medical issues. 5?7?, 135 pounds.
Initial pregnancy report received from a healthcare professional on 22 April 2013. A 35-year-old female patient, whose medical history, risk factors and concomitant medication were not reported, had received first dose of 0.5 ml ADACEL vaccine (lot number: U4612AA, expiry date: 09/20/15) intramuscularly on the right deltoid on 22 April 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period (LMP) date was on 20 August 2012 and estimated delivery date (EDD) was reported as 02 June 2013. At the time of report, the patient had not experienced any adverse event. Documents held by sender: none.
Strong tinitis, headache, malaise, and extreme fatigue. This began late evening on the day of the first injection, and has continued continuously from then until now, today August 10, 2021. I feel no confidence to receive the 'booster' (third vaccination) that is being talked about. I am immune compromised with Rheumatoid Arthritis.  Please be aware of this problem and advise.
Employee, a police officer had hit her head during struggle with an aggressive pt..  Vaccine at 1705.  Left after her 15 minutes observation and left to see a friend. Friend noted she was flushed. Employee felt her heart race and began to drive back to the hospital. She passed out and ran off of the road into a field; awoke and called for a medic; passing out while talking to the dispatcher. Upon arrival of the medic was awake and while walking in the field to medic she passed out again. In the medic woke up experiencing chills, shakes, nausea, vomitting and muscle soreness to her left side, left arm, her ribs, and shoulder blade.  Medic blood sugar 350IU, non diabetic. In ER normal.
After being vaccinated, was dead within 10 weeks; Pain was so bad; This case was reported by a consumer via social media interactive digital media and described the occurrence of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included neurological disorder nos and shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 3 months after receiving Shingles vaccine, the patient experienced death (serious criteria death and GSK medically significant) and pain. The patient was treated with analgesic, nos (Painkiller) and opioids {nos} (Opioids). On an unknown date, the outcome of the death was fatal and the outcome of the pain was unknown. The reported cause of death was death.   It was unknown if the reporter considered the death and pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient's son/daughter. The age at vaccination was not reported. The reporter stated that the patient had nerve disorder and then got shingles. After being vaccinated with Shingles vaccine the pain was so bad the patient needed pain intervention from a doctor who came to her at home and the reporter stated imagine pain that bad. The reporter stated that no amount of painkiller eased patient's pain, opioids too. The patient was dead within 10 weeks. The follow up would not possible as no contact information was available; Reported Cause(s) of Death: was dead within 10 weeks
CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SEQUELA 8/11/2021 SMALL BOWEL OBSTRUCTION
Had soreness at injection site, fatigue, weaker muscle cramps and headache, anemic.
Felt a little sick the day after. Significant arm pain for 2 days after. Starting 5 days after lymph node under armpit swelled to the size of a nickel (by 4/24/21) and was very painful. Returned to normal around 4/27. At about that same time lymph nodes under jaw began to swell and were painful by 5/1. This seemed to return to normal by 5/6. Since then no other adverse affects.
Patient reported a few red welts on her arm. They were not painful or itchy. Patient was instructed to ice the area.