chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received Tdap vaccine and experienced pain, redness and significant swelling after vaccine. Patient received antibiotic therapy, still managing reaction.
Information has been received from a nurse at an OB/GYN office concerning a 15 year old female who in January 2008, was vaccinated with a first dose of Gardasil at her pediatrician's office.  Post vaccination, the patient fainted almost immediately.  The patient also experienced the "seizure like symptoms" of uncontrollable shaking and eyes rolling back in her head for approximately 20 seconds.  Subsequently, the patient recovered and was sent home approximately 3 hours later.  It was reported that an electrocardiogram and blood work were performed (no results provided).  Additional information is not expected.
PATIENT CAME IN AND CLAIMED HER ARM STILL HURTS SOMETIMES. SHE SAID IT ALSO BLEEDS AND LOOKS PUSSY AT TIMES
This spontaneous report was received from a physician, via a company representative, concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 14-DEC-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2018, 0.5 ml (route and anatomical location of administration were not reported). On unspecified dates, the PNEUMOVAX 23 vaccine had five temperature excursions of 0 Celsius Degrees (32 Fahrenheit) for 168 hours, 0.55 Celsius Degrees (33 Fahrenheit) for 128 hours, -1.11 Celsius Degrees (30 Fahrenheit) for 264 hours, -1.66 Celsius Degrees (29 Fahrenheit) for 256 hours, -0.55 Celsius Degrees (31 Fahrenheit) for 368 hours, respectively. The vaccine status was reported as "in excursion" and the type of excursion and storage criteria were reported as "refrigerator (R)". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Rash all over body; off label use; Dose number=1: Moderna/Dose number=2: Moderna/Dose number=3: Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Jan2022 10:30 (Lot number: Fl3198) at the age of 23 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: BACTRIM. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: Ohob21a, Location of injection: Arm Right), administration date: 12May2021, when the patient was 22 years old, for Covid-19 Immunization; Moderna (Dose Number: 1, Batch/Lot No: Oloa21a, Location of injection: Arm Left), administration date: 09Apr2021, when the patient was 22 years old, for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 30Jan2022 10:30, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 30Jan2022 10:30, outcome "unknown", described as "Dose number=1: Moderna/Dose number=2: Moderna/Dose number=3: Pfizer"; RASH (non-serious) with onset 01Feb2022, outcome "recovering", described as "Rash all over body". The event "rash all over body" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of rash. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have known allergies and other medical history. Treatment received for the adverse event were Shot & pills of prednisone. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 2 month old male who received his first 2.0 ml oral dose of Rotateq. Subsequently, it was reported that he developed spitting up and trace amounts of blood in the stool which lasted for 3-4 days. it was reported that he was seen by the physician and has recovered. A product quality complaint was not reported. further information was not reported. Upon internal review trace amounts of blood in the stool was determined to be an other important medical event. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of heart fluttering in a elderly female patient who received SHINGRIX for prophylaxis. In December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 3 days after receiving SHINGRIX, the patient experienced heart fluttering (serious criteria GSK medically significant), injection site pain and influenza-like symptoms. On an unknown date, the outcome of the heart fluttering, injection site pain and influenza-like symptoms were recovered/resolved.  It was unknown if the reporter considered the heart fluttering, injection site pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 68 or 69 years old. The patient received a dose of SHINGRIX in the afternoon on an unknown arm. Within 24 hours after vaccination, the patient experienced flu-like symptoms and mild soreness at the injection site. The flu-like symptoms lasted for approximately 48 hours but the patient did not know how long the mild soreness at the injection site lasted because it did not interfere with her normal daily activities. The heart fluttering lasted for approximately three hours. The patient went to her physician that same day but the physician could not find anything wrong with her. The reporter gave permission for her physician to be contacted. The reporter consented to follow up.
lymphadenopathy; got cancer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 01Jul2021 (Batch/Lot number: unknown) as dose 2, 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; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: NEOPLASM MALIGNANT (medically significant) with onset Jul2021, outcome "unknown", described as "got cancer"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "lymphadenopathy". Clinical course: Caller mentioned that after the second dose of Pfizer Covid 19 Vaccine she got cancer and she also mentioned that she ''currently'' had lymphadenopathy.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dizziness, vision changes. Was hospitalized 4/20 through 4/22. She was having trouble with her vision.  Diagnosed with Stroke in the occiput region, was also noted to be in atrial fibrillation. Elevated blood pressure.
The night of when I got my vaccine I started to feel itchy around eyelids, forehead, cheeks couldn't open eyes all the way.  I looked in the mirror and my eyelids were swollen and red. My forehead too. I didn't take antihistamine, next day it was still bad so went to urgent care and nurse contacted doctor and check respiratory which was okay and I was discharged.  They said to take antihistamine 6 hours later I felt better, but still a little swollen.  I think the whole thing disappeared within three days later. This hasn't happened to me before with any other vaccine.
headache then vasovagal syncope then nausea/dry heave then hypoxia 02 ~ 80%
I had achy joints with both vaccines for several days.; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6205) via an unspecified route of administration, administered in Arm Right on 07Mar2021 14:30 (Age at vaccination: 69-year-old) as dose 1, single for COVID-19 immunization. Medical history included glaucoma, known allergy to bananas. The patient's concomitant medications were not reported. The patient previously took codeine and experienced allergy. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Patient had not been tested for COVID-19 since the vaccination. Patient had no COVID prior vaccination. Patient reported that she had achy joints with both vaccines for several days. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Immediately after completion of immunization the patient had an episode of near syncope. Was left in supine position with elevaton of lower extremities. Was conscious, mild pallor B/P 91/51 pulse 67. Stayed 15 min. Then placed on sitting position for 10 min. Drank water. Stood and walked for 5 min no dizziness, discharged home.
WAS SEEN AT THE ER ON 5/29 FOR FEVER. VACCINES GIVEN ON 5/28-RESULTING THROMBOCYTOPENIA PLATELETS 63. NO SEQUELAE OR COMPLICATIONG. SELF RESOLVED
It was reported post vaccine's pt started crying and cried through the evening. Pt developed a temp of 103F. Pt right thigh at injection site became swollen and blush color with light streaking.
This spontaneous report was received from a certified medical assistant concerning a multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ oral liquid (strength and dose were not reported) (lot # M039061, expiration date 28-APR-2018; lot # M034799, expiration date 01-FEB-2018) for prophylaxis. According to the reporter, ROTATEQ doses were exposed to the following temperatures excursions: 47 degrees Fahrenheit (F) to 77 F (9 degrees Celsius (C) to 25 C), and 31 F (-1 C) or colder. No adverse effects were reported. A digital data logger was involved. There was no product quality complaint involved. Additional information has been requested.
Patient vaccinated for COVID-19  on 04/07/2021 and 05/05/2021.  Patient began having symptoms of feverish, chills, and sore throat on 08/08/2021. Patient tested positive for COVID-19 on 8/11/2021.
BLOOD CLOT.  Began feeling ill 2 days after 1st vaccine...headache, cold and tired.  Developed pain in my abdomen area quite noticeable 4 days later.  6 days later had major pain, vomiting, bloody diarrhea.  Went to ER morning of the 7th day....spent 4 days in hospital.  Had a blood clot--Portal Vein Thrombosis.  Put on Heparin drip in hospital...and Eliquis blood thinners after released.  I have never been sick like that...never been on any prescription...always been healthy, walking 3-5 miles per day.   My family feels that there must be a connection with the vaccine.  One of my doctors said no...another said didn't think so, but unknown at this time.
Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
Breakthrough varicella s/p vaccine on 3/31/05, pink papular on chest, back, one small vesicles with swollen red mark on back, new lesions today
Pneumonia in early December. Hospitalized for 3 days. I tested positive for COVID-19 on 02/11/2022. I had aches and pains all over. It started as a cold that I normally get. Eventually, it turned into COVID-19. It ended up in my foot. My foot swelled up really bad and hurt. I got some steroids to take and that seemed to work.
AT 5:50 AM I WOKE UP WITH A HORRIBLE HEADACHE , INTENSE CHILLS AND FEVER OF 101.2 , I ALSO HAD NAUSEA, HAD SOME DIARRHIA LASTED FOR 48 HRS . HEADACHE WAS HORRIBLE . I TREATED SYMTEMS WITH TYLENOL AND A FLU MEDICATION THERAFLU.
Patient's daughter reported that about 2 weeks after second vaccine her mother became very ill. She was having trouble talking, walking, and moving. She stated that she had been taken to the hospital and it was possibly a stroke. We have since spoken with the patient on multiple occasions on the phone and she has not mentioned problems concerning her vaccine.
About a week after vaccination, the injection site became swollen, hot and red, and a little itchy. The initial pain and swelling from the vaccination had already subsided, so I thought it was weird that it returned. I have had the swelling/redness/itchiness for about 2 days now, and it is still present.
breast tissue tenderness, swelling and lymphadenopathy  Narrative:  Seen by PCP on 3/17/21 with what was believed to be inflammatory  breast tissue with lymphadenopathy, tenderness, swelling. States symptoms started  1/21/21 following receipt of 2nd vaccine. Breast ultrasound completed 3/18/2021,  reports believed to be related to COVID vaccine.   Other Relevant History:
feeling general weakness which is new; dizziness worse than normal; Loose bowels; This is a spontaneous report from a contactable other hcp (Nurse).   A 87-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6201, Expiration date: unknown), dose 1 via intramuscular, administered in Arm Right on 16Feb2021 14:00 as (Age at vaccination 87 years-old) dose 1, single for covid-19 immunisation. Medical history included atrial fibrillation episode, peripheral neuropathy, hyperlipidaemia-diet controlled vertigo, hypothyroid, bilateral mastectomy prophylactic, osteoarthritis and skin tape (known allergies: skin tape). Concomitant medication(s) included asa, gabapentin; levothyroxine and diazepam, all taken for unspecified indication start and stop date were not reported. The patient previously took bactrim (Bactrim Known allergies) and lovenox (Known allergies: Lovenox). On 18Feb2021 08:00 the patient experienced feeling general weakness which is new, dizziness worse than normal and loose bowels. Patient did not received any treatment for events. Facility type vaccine was administered at hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. The clinical outcome of all events were unknown.  Follow-up attempts are completed. No further information is expected.
firmness at the site of injection; itching at injection site; redness/pinkness at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (firmness at the site of injection), VACCINATION SITE PRURITUS (itching at injection site) and VACCINATION SITE ERYTHEMA (redness/pinkness at the site of injection) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031420A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, GLIPIZIDE, METOPROLOL, LISINOPRIL and WARFARIN for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2020,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE ERYTHEMA (redness/pinkness at the site of injection). On 24-Feb-2021, the patient experienced VACCINATION SITE INDURATION (firmness at the site of injection) and VACCINATION SITE PRURITUS (itching at injection site). At the time of the report, VACCINATION SITE INDURATION (firmness at the site of injection), VACCINATION SITE PRURITUS (itching at injection site) and VACCINATION SITE ERYTHEMA (redness/pinkness at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Woke up at 2am with swollen left eye, migraine, abnormal heart rate, and high blood pressure.  Few hours later I could feel the vaccine moving in my body to past injuries, ripped muscle in my back became swollen, that injury was at least 20 years previously. Heart rate was irregular and could feel blood pressure extremely high.  This continued for days as migraine and old injuries were affected. Face continued to be swollen and eye, migraine still present. On 10/19 I went to doctor as I was not getting better and at times I was much worse.  I went to a doctor, do not have a regular doctor as I am never sick and allergic to any meds in the past. The doctor took blood pressure, very high, did ekg, chest X-ray, blood work,  and suggested being referred fir the migraine.  After seeing the doctor I made an appointment with eye doctor, eyes were fine. Still am experiencing issues
The day of my shot I was okay until around 11PM, I had a round rash develop were the needle went into my arm. The next morning it was larger and was moving down my arm. I called my doctor and the doctor said it would go away in a few days, at which tie it did. However a few days later my tongue started to burn and it still feels like its burning and my doctor cant explain that. My ear has also been hurting.
Pt received injection on 02/20/2021 and tolerated well. Pt contacted PCP office and spoke with triage RN on 02/23/2021.  Pt woke up on 02/23/2021 and after taking her shower noticed redness, swelling and warmth at the injection site. area was 4" and now appears to be approx. 2.5" in diameter. Pt monitored the area and in the afternoon the symptoms resolved. Pt denies chest pain, shortness of breath, fevers, chills, rash/blisters and swollen glands at the time of the triage call. RN provided pt with home care instructions for her to continue to monitor for reaction to COVID vaccine, take Tylenol as needed and apply cool compresses tot he area with barrier between skin/ice as needed. Pt returned telephone call to the PCP office and spoke with triage RN on 02/25/2021 and advised the area of redness has extended to her left elbow. Pt reports no " red streak noted" its only red, warm to touch and with no swelling/pain or fever. RN sent message to PCP and recommendations received and RN contacted pt. RN advised pt to continue with ice as needed, Tylenol as needed and reviewed instructions for worsening symptoms and when to present to hospital ( increase redness/warmth/fever) and ED ) red streak/increase pain/swelling/high fever/decreased movement to left arm).
Patient had no known side effects; Vaccine reached (34.3F); This spontaneous report was received from an administrator and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-JAN-2022, the patient was administered a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ)(strength, lot #, and expiration date were not provided) for prophylaxis. Prior to administration, the vaccine experienced temperature excursion of 34.3 degrees Fahrenheit for 4 hours 23 minutes and 0 seconds (Product storage error). There were no previous excursions. Patient had no known side effects (No adverse event).  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA006297: US-009507513-2201USA005595: US-009507513-2201USA005673: US-009507513-2201USA005751: US-009507513-2201USA005901: US-009507513-2201USA006295: US-009507513-2201USA006305: US-009507513-2201USA006322: US-009507513-2201USA006342: US-009507513-2201USA006419: US-009507513-2201USA006445: US-009507513-2201USA006297:
On 4/4/00 at 15:30, started with lower back and hip pain and low-grade fever. Took Nuprin without relief and was advised to see PMD. On 5/2/00, call to client (out of country) and so left message to call HD when returns.
Developed COVID-19 after being around family members that weren't vaccinated; Took a home COVID-19 test and was positive; Called the local clinic and was prescribed PAXLOVID.
Initial case was received from a healthcare professional on 06 February 2013. A 36-year-old male patient, whose past medical history was not reported, received an injection of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE, MFR UNK, (lot number, route, site, side and dose in series not reported) on an unknown, unspecified date as a small child. On an unspecified date, "shortly" after vaccination, the patient was paralyzed from the waist down, which lasted for six months (mos). The reporter did not have any other information about the vaccination and would not be able to obtain information since the patient was not vaccinated at the reporter's facility. The reporter was unable to obtain information about what facility or from which provider the patient had received the vaccination. The reporter did not want further contact for this vaccination. The patient's outcome was reported as recovered on an unspecified date. Documents held by sender: None.
This spontaneous report was received from a registered nurse and refers to a multiple patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On unknown dates, multiple patients received doses of improperly stored (Oka/Merck) VARIVAX (lot # K002917, expiration date: 26-FEB-2016) (dose and route of administration were not reported). No adverse effects were reported. Administered doses of (Oka/Merck) VARIVAX experienced the temperature excursion of -6.5 degrees Celsius for 1 hour and 12 minutes. Data logger was involved. The previous temperature excursions were at -7.4 degrees Celsius for 2 hours and 36 minutes. Since dates of (Oka/Merck) VARIVAX administration were not known, it was unknown whether the vaccines, that at the time of the report (also reported as currently) were expired, were administered to the patients prior to expiry or after expiry (considered as expired vaccine used). Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received Moderna COVID vaccine on 1/25/21 and 3/4/21. On 1/22/22, patient admitted to our inpatient unit with acute hypoxemic respiratory failure and pneumonia due to COVID-19 and acute encephalopathy.  As of today (1/17/22), patient is still admitted in our med/surg unit.
Tenderness and approximately a 5" diameter of flushed or pink skin around the site of the injection which was also slightly swollen and warm to the touch,  lasting 6 days.
A nurse reported that a child received an injection of Prevnar and subsequently, developed a "red lacey rash all over". The child also developed swelling at the injection site. No further information was available at the date of this report. The reporter declined to provide information for follow-up investigation.