chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed severe bilateral pneumonia with respiratory failure requiring ICU Admission. SARS CoV-2 RNA, RT- PCR tested positive
she experienced fainting the next morning; 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 female patient 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 (Dose number: Unknown, Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "she experienced fainting the next morning". Clinical course: As per agent (Name Withheld), caller was asked has anyone experienced fainting after the booster vaccine. after providing response, caller stated that she experienced fainting the next morning. Caller mentioned that she received her vaccine 2 PM and fainted the next morning at 6 AM when she got out of bed. Caller stated that she wondered if that was from the vaccine and she had called the pharmacy and they told here that they have no records of patients fainting after the vaccine administration.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient returned to pharmacy on 8/17 to pick up a medication and informed the pharmacy that after she received her  vaccinations on 8/13 she developed a rash on her arm that then became swollen on her arm.  She stated she researched it on the internet and said she read about "covid arm." She thought that is what she had. She stated she iced the area, took ibuprofen, and took only one benedryl. She stated that her arm was getting better after a couple of days since the vaccination.
-HEART RACING...FRIDAY NIGHT AFTER VACCINE...LASTED 5 HOURS UNTIL PATIENT WENT TO SLEEP- NOT TREATED -SWELLING OF ARM AND REDNESS /WARM TO TOUCH/TENDERNESS...EXPECTED--USE ICE PACK, TOOK ONE 200MG TABLET ADVIL -SWOLLEN GLANDS UNDER NECK REGION--NOT TREATED, , SEEN 2 DAYS AFTER SHOTS -DIFFICULTY SWALLOWING - NOTICED TODAY , 2 DAYS AFTER SHOT-NOT TREATED -DID NOT REPORT ANY SWELLING OF TONGUE OR SOB OR DIFFICULTY BREATHING
15JUL93 parent screened for immun pt denied allergies to med, eggs, hx of convuls, prev immun react; mom also denied current illnesses; pt recvd vax & 10 mins later pt fainted; unconsc lasted approx 5 sec VS BP 110/70, P60, R22;
Approx 7-8 days after vaccine patient got localized redness, swelling and itching that lasted 3-4 days
Information has been received from a medical assistant referring to an unspecific number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were administered improperly stored doses of COMVAX (dose, route, lot# and expiration date were not reported). Concomitant drug was not reported. No adverse events were reported. This is one of the 3 reports reported by the same reporter. Additional information has been requested.
Pt began to experience tingling sensation in face. No dysphagia or aphasia. Eyes PEARL. Denies weakness to one side of body. Strength normal w/ neuromotor assessment unremarkable. Pt brought to evaluation area. Vitals and physical assessment obtained. Findings WNL. Pt given water w/ no difficulty swallowing. Pt is independently ambulatory. Pt condition improving over the course of 20 minutes. Symptoms not present by time of final encounter. Pt educated on next course of action. Pt released w/ all Pt questions asked and answered.
An extreme period -- longer than usual, increase in cramping, lighter flow, fluctuating hormonal changes - increase in severe depression. Patient is in recovery from an eating disorder and thought she was relapsing. Acne, hot flashes, bloating.  All of the above were increased/multiplied in first period after receiving the first dose of vaccine.
I had the hepatitis B vaccine. After 2 doses I started having headaches and numbness on my left side. I went to the hospital for testing (MRI) and was told I had a brain tumor. At the next week, a biopsy was done and the results came back demyelination. Went to the doctor and he said it was from the vaccine. I had one seizure not long after the biopsy was done. I also went to the hospital to have another biopsy done because my doctor was telling me he thought I may have a tumor because the lesion would swell up and then go down. When I got to the hospital they said it could not be a tumor the way it was responding to steroids. I also had a PET scan done and that was fine. All of my 3 spinal tests have been negative for me, but that is what I am being treated for. I was never sick before this except sinus headaches etc. I have four healthy children and three healthy siblings.  60-day follow up on 01/28/04: "Pt has not recovered from adverse events. Multiple sclerosis or MDEAM. It would be nice to find a doctor would believed this is what happened and would listen to you, my MRI has not changed for 2 years."
05Nov97 Pt recv vax. 09Nov97 Pt devel over 100 lesions. Pt was out of work for 7 days.
-Since 2009 she had been diagnosed with chronic migraines - between 15 to 20 a month. - Loss of appetite from 115lbs to 86 lbs. - Nausea - Rashes. - Bruises easily. -Shortness of breath. - Fatigued easy.  - Gallbladder removal. - Joint pain received the regular dosage as prescribed by a doctor in the three time interval.
As expected, flu-like symptoms the next day. Following day itching burning red blotches and spots upper chest, upper back, shoulders, both arms.  Spoke to pharmacist on day 4, suggested I call Doctor,  take benedryl.  a few spots growing centers. Spoke to nurse practitioner day 5,  Take benedryl , speak to Allergist, report to VAERS. no new spots that day, and burning less acute. Spoke to Allergist day 6, spots and blotches beginning to fade, but still evident. Advised to discontinue series and report to  VAERS.  No new breathing issues throughout.  day 9 (today) blotches still evident, though faded, spots  less numerous.
Painful flu shot - sore for a couple of days (soreness gradually subsided) - movement affecting daily activities - chiropractor stated may have hit bursa (SIRVA).
Covid19 breakthrough.  1st vaccine received on 01/11/2021.  94 y/o with PMHx of DM type 2, HTN, HLD, CAD s/p CABGx4, GERD, BPH with LUTS presents to ED via EMS for c/o SOB and generalized weakness.  EMS found pt with O2 sats in the 80's, placed on 4L NC.  CXR with possible atypical viral PNA. Afebrile.  Pt started on Steroids and then Remdesivir added.
Extensive swelling at injections site, this is resolving. Erythema proximal to her elbow with very mild extension and tenderness on her lateral anterior chest wall. Patient will use ibuprofen, warm compress and a trial dose of Benadryl.  Return if symptoms worsen or fail to improve
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 04-AUG-2017 the patient received an expired dose of ZOSTAVAX lot # M009773, expiry date: 17-MAY-2017 for prophylaxis (expired product administered).  Concomitant therapies included sterile diluent(STERILE DILUENT) (lot # N001534, expiry date: 30-JUL-2019).  No adverse effect reported. No Product Quality Complaint (PQC) was involved.
started with a sore throat... throat condition worsened... was in undisclosed location, went to urgent care, they indicated results from flu, strep, and covid were negative... started a slight fever, tired.. returned home. took a covid home test two days after urgent care and results were positive.. contacted my dr. who then prescribed paxlovid and z pak...   My throat was the worse that happened.. was over within 5 days.
about 10-15mins p/vax pt reported difficulty swallowing; BP 158/120; EMS called & transported pt to ER; Adrenaline administered; BP came down to 152/84, diff in swallowing subsided;
experiencing a temperature of 101. 5 degrees; Threw up; Slight rash; Complaining of chest pain; it feels easier to breath, almost too easy to breathe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer. The reporter is the parent.  A 13 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 13 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunisation. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "experiencing a temperature of 101. 5 degrees"; VOMITING (non-serious), outcome "unknown", described as "Threw up"; RASH (non-serious), outcome "unknown", described as "Slight rash"; CHEST PAIN (non-serious), outcome "unknown", described as "Complaining of chest pain"; RESPIRATION ABNORMAL (non-serious), outcome "unknown", described as "it feels easier to breath, almost too easy to breathe". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts have been completed and no further information is expected.
no further AE's from the administration; administration of PROQUAD to a patiet intramuscularly instead of subcutaneously; This spontaneous report has been received from a medical assistant, concerning a 4 year old male patient . The patient's medical history and concurrent conditions were not provided.   On 27-MAY-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) intramuscularly instead of subcutaneously, at a dose of 0.5 milliliter one time, lot # T037957 with expiration date 09-MAY-2022 for prophylaxis which was reconstituted with sterile diluent. No further adverse events from the administration.
For the first two days following vaccine administration, I felt debilitating body aches and chills. Once that ended, I began feeling neurological symptoms. For two weeks following vaccine administration, I felt random, sporadic tingles or "shocks" on my arms, legs, torso, neck, and face. These occurred at random times (all times of the day) and were sometimes painful. Once these ended, I began seeing hives on both arms, torso, etc. in strange patterns and have continued to have these to date, nearly one month after the vaccine. These do not subside with Cortisone or Benadryl.
1.  I was completely normal the day of the second dose. 2.  The next day, I had quite significant chills, body aches, fatigue, and some nausea.  I also had a metallic taste.   3.  Fortunately, the chills, body aches, and fatigue went away the second day.  However, I continued to have the metallic taste for days. 4.  Also, starting the third day and I still have a cough and tightness in my lungs.  I went into a doctor at urgent care four days after the second dose (due to a concern about the cough and tightness in my lungs).  All of my vitals were normal and they attributed to side effects from the vaccine.  Also, they gave me an inhaler. 5.  The inhaler has been somewhat helpful, but I had a consistent cough as well as  some tightness in my lungs for two weeks after the second dose.  On unusually stressful days, it was even worse. 6.   The cough has improved, but I still have it occasionally throughout the day as well as the tightness in my lungs.   7.  Finally, I continue to have the metallic taste.
0.25 ml booster dose of Moderna given when patient needed 0.50 ml second dose. Called patient, he returned for 2nd dose of 0.50 ml per CDC guidelines
There was a raised, red area around the injection site (the area around the injection site affected was about the size of a large walnut).  It first became noticeable approximately 6 hours after the vaccination.  I phoned my physician's office and I spoke with the consult nurse.   She consulted with my physician and phone me back.  I was advised to ice the area, and take benadryl.  I was also advised to follow advice on forms provided by clinic where vaccination was given at.   Over the next 2 days (until 03/11/2021) the red, raised area increased in size to approximately 2 inches around the injection site.  It continued to hurt and itch excessively.  It began to start fading and lessening in size over the next 2 days until it was almost unoticeable on 03/13/2021.
pt lost conscious briefly in lobby; cold to touch, pale color; shallow, resp 18, P82; pt hit head;
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 02-MAY-2017, the patient was vaccinated with  a dose of ZOSTAVAX lot # M001746, expiration date on 07-APR-2017 (strength, dose number and route were not provided) for prophylaxis. Other suspect therapies included sterile diluent(manufacturer unknown). No adverse effects were reported. Additional information has been requested.
Client became pale, diaphoretic & faint within one minute of receiving shots. Assisted him to the cot where he lay with legs elevated & drank juice x 5 minutes. He sat on the side of the cot x 3 minutes.  He felt fine & was able to leave in the care of his grandmother within 15 minutes.
Breakthrough case admission after 4 vaccines Pfizer 4/20/21 Lot# ER8732;  Pfizer 5/19/21 Lot# ER8732;  Pfizer 12/2/21 Lot# FJ8727;  9/30/22 Pfizer Lot# GH9693
This spontaneous report as received from a pharmacist refers to a 67 years old female patient with a history of chest colds and a long standing order of prednisone. On 09-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous in the right arm (dose number, lot/batch number and expiration date were not reported)(indication reported as vaccination) concomitant with a dose of an unspecified flu vaccine in the left arm. In approximately September 2014, the patient experienced chest cold. The event was treated with prednisone 60 mg. The reporter also asked about steroid use in relation to ZOSTAVAX. The outcome of chest cold was reported as not recovered/not resolved. The reporter considered chest cold to be not related to ZOSTAVAX (reported as had anything to do with the chest cold). Additional information is not expected as no consent for contact was given.
migraine; sick; awful smell and taste; awful smell and taste; This is a spontaneous report from a contactable other healthcare professional, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Feb2021 at 15:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included adhd (attention deficit hyperactivity disorder), depression and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine/saccharate/dexamfetamine sulfate (ADDERALL), bupropion hydrochloride (WELLBUTRIN) and vitamin d nos (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 23Jan2021 at 13:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The previously received ciprofloxacin (CIPRO) on unknown date for unknown indication and experienced drug allergy. On 18Feb2021 at 12:00, after second shot, the patient had experienced migraine about a week later and got sick and since the patient had an awful smell and taste that was present often, when the patient had COVID-19 she experienced smell and taste was affected it took about a month or so to get her taste back somewhat and smell had never been the same. The events did not result in doctor or other healthcare professional office/clinic, 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 migraine, sick, awful smell and taste was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
I developed several vertigo, dizziness and was diagnosed with BPPV by my doctor 5-6 days after my last vaccination.  I am still having symptoms to this day as treatments and physical therapy have not worked.
This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 62-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020) for prophylaxis. Co-suspect products included MMR vaccine for prophylaxis. On 9th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml and MMR vaccine. On an unknown date, less than a year after receiving SHINGRIX and MMR vaccine, the patient experienced hives. On an unknown date, the outcome of the hives was recovered/resolved. It was unknown if the reporter considered the hives to be related to SHINGRIX and MMR vaccine. Additional details reported as follows: A patient experienced hives after receiving SHINGRIX on right deltoid which was given on the same day as the MMR vaccine. The healthcare professional was unable to read lot number last digit could be 3, J, or S. Unsure of when hives started after vaccination. The reported batch number HG4PS for SHINGRIX did not exist and was updated to HG4P3 as per the sales database.
no adverse event; expired vaccine used; This spontaneous report has been received from a nurse concerning to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 28-JUN-2021, the patient was vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 ml orally (lot#: 1684163, expiration date: 26-JUN-2021) as prophylaxis (expired product administered). The product had no prior temperature excursions. No additional adverse events were reported.
heart palpitations 3 days after receiving the Pfizer vaccine; menopause; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, 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: PALPITATIONS (non-serious), outcome "unknown", described as "heart palpitations 3 days after receiving the Pfizer vaccine"; MENOPAUSE (non-serious), outcome "unknown". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
headache; tested POSITIVE to COVID test; sinuses; body aches; colds; sore throat; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested POSITIVE to COVID test), NASOPHARYNGITIS (colds), OROPHARYNGEAL PAIN (sore throat), SINUS DISORDER (sinuses) and VACCINATION SITE PAIN (Arm pain) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ASCORBIC ACID (VIT C) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm pain). On 24-Mar-2021, the patient experienced NASOPHARYNGITIS (colds) and OROPHARYNGEAL PAIN (sore throat). On 25-Mar-2021, the patient experienced SINUS DISORDER (sinuses) and MYALGIA (body aches). On 26-Mar-2021, the patient experienced COVID-19 (tested POSITIVE to COVID test). On 27-Mar-2021, the patient experienced HEADACHE (headache). The patient was treated with IBUPROFEN (oral) at an unspecified dose and frequency. At the time of the report, COVID-19 (tested POSITIVE to COVID test), NASOPHARYNGITIS (colds), OROPHARYNGEAL PAIN (sore throat), SINUS DISORDER (sinuses), VACCINATION SITE PAIN (Arm pain), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant concomitant medications included, Centrum Multivitamins for women were reported.  .
BLOOD CLOT TO THE BIG TOE; FOOT WAS GETTING INFECTED/BOTH TOES FOOT WERE RED; SWELLING OF TOES/GOT VERY HARD/BOTH TOES IN BAD SHAPE; NAIL REMOVED, FLESH CUT OFF WITH THE NAIL; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot to the big toe. It was reported that on 25-MAR-2022, patient visited hospital and seen a foot doctor and other doctors, both her toes were in bad shape, nail removed, flesh cut off with the nail and toe was swelled up (got very hard). Doctors performed surgery on her blood clot on her toe a couple of weeks ago. The foot doctors did not know what it was. They took out the blood clot. Patient's mother reported that patient's other toes were also red, they had not done any surgery on that one. Both toes on the other foot were red. The other foot was getting infected. Patient's mother was unable to determine which foot was originally affected and was seeking medical advice.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot to the big toe, foot was getting infected/both toes foot were red, swelling of toes/got very hard/both toes in bad shape, and nail removed, flesh cut off with the nail. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220355692-Covid-19 vaccine ad26.cov2.s- blood clot to the big toe.The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Constant sneezing, itchy and watery eyes, hives broke out on scalp and body. Some scratchy/dry throat
Information has been received from a RN concerning a 17 month old Native American male with mild hearing loss who on 18Apr05 was vaccinated SC in the right arm with the first (0.5mL) of varicella virus vaccine live (lot649266/0645P). Concomitant vaccinations on that same day included the fourth IM dose in the right arm of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (lotC2103AA). The RN reported that on 21Apr05, the pt developed hives on his torso. The RN also reported that on 27Apr05, at 10:45, the pt developed red papules and pustules on his arms, legs, neck and torso. On that same day, the pt presented to the clinic. At that time, the pt was afebrile and the pustules and papules were noted to be non-pruritic. The pt was behaving normally and did not see bothered by the eruption. At the time of the report the pt was recovering. No further information is available.