chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician's assistant concerning a female who on 18-JAN-2007 was vaccinated with Gardasil. There was no concomitant medication. After vaccination on 18-JAN-2007 and 22-MAR-2007, the patient experienced bleeding gums. The duration and extent of the bleeding gums was unknown. It was unknown if the bleeding got worse with the second vaccination. The patient's father is an oral surgeon and felt that the bleeding of the gums was related to the Gardasil vaccination. The patient's bleeding gums persisted. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/16/2007. Initial and follow-up information has been received from a physician's assistant concerning a female who on 18-JAN-2007 was vaccinated IM with a first dose of GARDASIL vaccine (Lot# 654702/0011U). There was no concomitant medication. Subsequently, the patient experienced bleeding gums. On 22-MAR-2007 the patient was vaccinated IM with a second dose of GARDASIL vaccine. Subsequently, the patient experienced bleeding gums. On 12-JUL-2007 the patient was vaccinated IM with a third dose of GARDASIL. Subsequently, the orthodontist noted "bleeding gums" after the third dose. The orthodontist felt that it was caused by "something new in the bloodstream." The duration and extent of the bleeding gum was unknown. It was unknown if the bleeding got worse with the second vaccination. The patient's father is an oral surgeon and felt that the bleeding of the gums was related to the GARDASIL vaccination. The patient's bleeding gums persisted. Additional information has been requested.
Pt received vaccine on 4/24/09.  She called on 4/27/09 to report that later 4/24/09 in the pm she broke out with a rash that looked liked chickenpox and was itchy.  Stated started weeping and now crusting over.
This spontaneous report as received from a nurse refers to a 56 year old patient with unknown gender. No information regarding the patient's medical history was provided. on 25-JAN-2013 the patient was vaccinated with PNEUMOVAX 23, 0.5 ml intramuscular, after its expiration date. Lot number was reported as 0631AA (expiry date: 21-JAN-2013). No concomitant medication was reported. No adverse effect was reported. No outcome was reported. Additional information has been requested.
CREUTZFELDT-JAKOB DISEASE; TINY TUMOR IN THE FRONT OF BRAIN; AFRAID AT NIGHT TO STAY ALONE; This spontaneous report received from a consumer concerned a 62 year old female. The patient's weight was 230 pounds, and height was 67 inches. The patient's concurrent conditions included high blood pressure, non alcoholic, and non smoker. Patient had no known allergies, no drug abuse or illicit drug usage. Patient had always been independent, intelligent with outstanding memory The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiration date was unknown) dose was not reported,1 total, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  After 3 weeks receiving the vaccine, patient went downhill. On 29-MAR-2021, the patient had, complained of arm being numb and started forgetting things. She started having very bad memory issue, was afraid at night to stay on her own and was agitated and emotional. She also had coordination issues, could not get into the car on her own, could barely stand up from the sitting position and would go side by side when walking. She could not form an understandable sentence so she was taken to the hospital and hospitalized from 31-MAY-2021 to 17-JUN-2021. Then she was taken to Psychiatric unit and sent her home with an appointment to see a neurologist. On 03-JUL-2021, patient was found naked on the kitchen floor, she could not remember anything and nothing made sense.  She was taken back to the hospital with the ambulance and later on (unknown date) the hospital transferred her to the another hospital, at the time of reporting patient was hospitalized there. They did computerized tomography scan, Magnetic resonance imaging, lumbar puncture and blood  works but did not have any results. During hospitalization they found a tiny tumor in the front of the brain and diagnosed Creutzfeldt-Jakob disease. The hospital also said no dementia and no Alzheimer's disease. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiny tumor in the front of brain, and creutzfeldt-jakob disease, and the outcome of afraid at night to stay alone was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210760791-covid-19 vaccine ad26.cov2.s-Creutzfeldt-jakob disease and tiny tumor in the front of brain. This event(s) is considered un-assessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Received vaccine about 7pm. Upon awakening 6/18/19 pt experienced Nausea, sweats, chills, diarrhea, knee pain, all-over aches.
Chills, body aches, severe arm pain at injection site and down to elbow in triceps.  Altrhough not quite as painful as it was on the day of injection, I still have triceps pain.
Information has been received from a medical assistant concerning an 85 year old male (weight 168#) with hypercholesterolaemia, hypertension, glaucoma, coronary artery disease and an allergy to niacin who on 16-NOV-2006, was vaccinated subcutaneously with the second dose of Pneumovax 23 (lot #655500/1005F).  Concomitant therapy included ezetimibe (MSN), COUMADIN, lisinopril (manufacturer unknown), TOPROL XL TABLETS, LIPITOR, OCUVITE PRESERVISION, XALATAN, PRILOSEC and METAMUCIL.  On the morning of 17-NOV-2006, the patient called the office because his arm was swollen, red, warm to the touch, and very painful from the shoulder to the elbow.  He was prescribed unspecified antibiotics.  No lab studies were performed.  The patient's outcome was reported as recovered.  No product quality complaint was involved.  Additional information has been requested.
This spontaneous report as received from a nurse refers to a 2 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 22-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N008823, expiry date: 26-MAY-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
On 10-1-21, the patient received 2nd dose of Pfizer. Two weeks later Pt suffered itchy bumpy rash on legs, arms, back. Patient was treated with Medrol (1-26-22) and a second MEDROL (2-8-22). Dermatologist prescribed (2-8-22) Hypersensitivity unresolved-
She develop a fever, irrability, decrease in appetitie and diarrhea that I could not control at home which resulted in an ER visit.
Pt has been hospitalized since 9/8/2021. Pt was tested for COVID per protocol prior to transfer to nursing home and tested positive.  Symptoms are sore throat.
Was a little congested with a headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Was a little congested with a headache) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced HEADACHE (Was a little congested with a headache). At the time of the report, HEADACHE (Was a little congested with a headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, COVID-19: negative (Negative) Negative. On 18-Apr-2021, COVID-19: positive (Positive) Positive. On 24-Apr-2021, COVID-19: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041a21a, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced arm soreness. On 05-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness on 08-APR-2021, and fatigue on 07-APR-2021. This report was non-serious.
8/30 & 10/20 grand mal seizures; loss of conscientious. Prior to seizure a very hot feeling came across; almost like a massive anxiety attack feeling. Last event had injuries.
Patient reported that her right hand has a painful rash.  Told her if it was an allergic reaction Benadryl will help, but reccommended she contact her Dr for treatment.  Also recommended she go to the ER if the reaction progresses including any swelling of the lips, tongue, or throat or difficulty breathing.
Sore soft tissue around injection site for about 18 hours after injection; This is a spontaneous report from a contactable consumer or other non hcp.   A 47-years-old male patient received bnt162b2 (BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EL3248), dose 1 via an unspecified route of administration, administered in Arm Left on 02Mar2021 07:30 as SINGLE DOSE for covid-19 immunisation. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. Medical history included gout, nephrolithiasis. Concomitant medication(s) included multivitamins (MULTIVITAMINS; probiotics (PROBIOTICS); cholecalciferol, ubidecarenone (COQ10 + D3); fish oil (FISH OIL); ergocalciferol (VIT D). It was Reported that, the patient experienced sore soft tissue around injection site for about 18 hours after injection on 02Mar2021 with outcome of recovered. Follow-up (10Mar2021): This is a follow-up spontaneous report in response to mail trail sent regarding the confirmation of below mentioned query. This reported included   Follow-up (11Mar2021): This is a follow-up spontaneous report in response to mail trail sent regarding the confirmation of below mentioned query. This reported included that.  No follow-up attempts are needed. No further information is expected.
pt started shaking & having sz type activity lasting a couple mins in duration; pt was not taken to ER; sx subsided;
Child cried continuously with high pitch cry for 1 day. No other symptoms. Diagnosis: reaction to Pertussis.
Eyes "shook", arms stiffened, body trembled lasted 10 seconds, urinary incontinence, abdominal pain, vomiting.
head numbness and tingling; head numbness and tingling; This is a spontaneous report from a contactable consumer (patient) reported that a 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiration date: 31Mar2021), via an unspecified route of administration on the left deltoid on 09Jan2021 12:00 at a single dose for Covid-19 immunization. The vaccine was administered at a hospital. Medical history was reported as none. Family medical history included her mother has multiple sclerosis and her sister has lupus. There were no concomitant medications. On the 9th, this past Saturday, she had first dose of COVID vaccine. Then on Monday, the 11th around 2:00 pm (14:00), she started having in her head numbness and tingling. Still has numbness and tingling in the head. The outcome of the events was not recovered.
Within 20 minutes of the shot, fingers became stiff and slightly swollen. Within 4 hours, most finger tips were mild to moderately numb. 3 Finger tips remain slightly numb (3 days later). Joints ache and feel "weak" (1 day to present [3 days later]). Outside of calves felt moderately numb 4 hours after the shot until end of 2 days. Remaining symptom of weak ankles, weak legs, joint pain and mild aches of joints, and pressure around the head continues.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Patient medical history and drug allergies were not reported. On an unknown date, an unspecified number of patients received improperly stored VARIVAX lot number: K020756, exp date: 30-APR-2016 (invalid lot) (dose, strength and route were not reported). No concomitant medications were reported. No adverse effects were reported. Lab tests were reported as unspecified. The outcome of the event was unknown. There was no product quality complaints (PQC) involved. The reporter's causality assessment was not provided. Additional information has been requested.
I noticed left ear, left face, and left TMJ pain  ~ 48 hours post 2nd- Pfizer vaccine.  I noticed headaches and increasing ear/TMJ pain up until today (1/28).  The TMJ and ear pain is less today, but it's still difficult to open my mouth.  I have tried Tylenol and Ibuprofen to alleviate the discomfort, but the OTC meds to not help.
Local reaction - itching following injection, following day progressed to full body hives, 3rd day swelling on hands and eyelids.
Rash; chills; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and CHILLS (chills) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blood pressure high and Arthritis.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced RASH (Rash) and CHILLS (chills). At the time of the report, RASH (Rash) and CHILLS (chills) outcome was unknown. Not Provided          No concomitant medications were provided. Treatment medication reported includes Tylenol.
rt arm 1 1/2x original size by 530PM, hot to touch & sensitive, flu-like sx lasted 5 days;19OCT97 UTI, nausea & vomiting;currently on ATB for the infect;
Chicken Pox had Varivax on 12/29/1998. Red based lesions on chest back and arms itching)
Painful rash on her face; This case was reported by a consumer via call center representative and described the occurrence of painful rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2022, the patient received the 2nd dose of Shingrix (intramuscular). In April 2022, 3 days after receiving Shingrix, the patient experienced painful rash. The patient was treated with prednisone. On an unknown date, the outcome of the painful rash was not recovered/not resolved.   It was unknown if the reporter considered the painful rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-JAN-2023 Reporter's comments: The reporter was the patient. She had received her second Shingrix dose via intramuscular route in April 2022. Three days later, she had developed a painful rash on the right side of her face. She had seen three physician, but the cause of rash was unknown.  She had skin scrapings done but they were negative. Three days earlier before the time of reporting, she had completed a three week course of prednisone and the rash improved but was now back again. Nothing else was reported. The reporter did not consent to follow-up.
presented to the Emergency Department with shortness breath and hyperkalemia in the setting of COVID-19 infection via EMS. Respiratory: Positive for cough and shortness of breath
Patient called today 12/29/04 states that after one week of having vaccines of PPV23, right arm swollen with pain, redness, and hot to touch. Patient was seen at hospital and states his right arm MD. Diagnosis of cellulitis after the Pneumonia shot. Patient was given medication at hospital per his statement.
Patient with multiple co-morbidities including Gastroesophageal cancer presented to the ER after he spiked a fever of 100.8 F. Admitted with concern for drain displacement and fever on 1/7/21. The patient remained afebrile overnight. Imaging was evaluated by IR and the fluid collection was deemed to minimal to warrant intervention. Surgery evaluated the patient and concluded that no acute intervention was necessary. It is most likely that the patient's fever was a reaction to administration of the COVID-19 vaccine.  The patient was deemed stable for discharge on 1/8 and sent home on 5-day course of antibiotics.
Patient had signs and symptoms of cellulitis which caused her to go to the doctors and get treatment.  Patient has not returned my calls to tell me what treatment of how long she had to be treated.
having flu symptoms last week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: Bnt162b2 (DOSE 1, SINGLE, He has had all Pfizer shots and a couple of boosters.), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, He has had all Pfizer shots and a couple of boosters.), for COVID-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset Aug2023, outcome "unknown", described as "having flu symptoms last week".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300281456 same reporter and drug; different events;
On July 6, 2022 I had a scratchy throat and headache, tested with a home COVID-19 test that came back negative. The next day I had the same symptoms but my throat was now sore but I still was testing negative. On day three I was having crazy dreams, fatigue and the home COVID-19 came back positive. I called my primary care physician and had a telehealth visit and was prescribed PAXLOVID. I started taking the medication that night and I am feeling much better.
The day of shot, the injection are was sore. The next lot of days the injection grew as big as a grapefruit! It was to touch and my are was painful to move. I felt like I was hit by a truck for three weeks! I did call the pharmacy and they said there were no complaints and this was the first they ever heard of it. I needed to miss work, take pain killers, and rest for an additional three weeks. So disappointing, that the pharmacists' took no interest in the complaint. To this day, I still feel a lump in the injection side. My left arm.
Patient presented for 5 vaccines for travel. Administered Spikevax and VAQTA intramuscularly into left arm,  Fluzone Quad and Boostrix intramuscularly into right arm. After 4th shot, patient began to feel light headed and stated that they did not eat anything for the day. Patient's head began to nod off 10 seconds later and patient began to sway back. Patient slumped over and black-outed for 2 seconds and became alert right after. Pt monitored till better.
Mom called to just let us know that the day after patient's shots and maybe for a few days after his arms hurt to move. She can't remember today 6/25/01 if she used tylenol. no redness noted on arms no swelling noted either. state nothing bothering patient now.
Began with malaise the night of the shot. Patient had pretreated with ibuprofen 400mg x 1 and continued every 4-6 hours. Next morning there was a large red mark around injection site, about 3 inches in diameter, which grew throughout the day to 6 inches in diameter. Slight fever, (99-100F), flu symptoms (runny nose, achy body), later on these symptoms became so severe that the patient went home early from an event. Symptoms continued for 3-4 days till late Tuesday, with lack of energy persisting the longest. Patient was better by Wednesday morning.
18JUN92 11AM pt recvd vax & 7PM had fever of 102.4; APAP given; began vomiting & c/o h/a;
With in 48 hrs started to develop rash on temple area of face spread throughout face with swelling and small pumps; With in 48 hrs started to develop rash on temple area of face spread throughout face with swelling and small pumps; With in 48 hrs started to develop rash on temple area of face spread throughout face with swelling and small pumps; very warm to touch and ears were very hot/red and itchy; ears were very hot/red and itchy; ears were very hot/red and itchy/Also developed itchy hives in right wrist area and around both knees.; Also developed itchy hives in right wrist area and around both knees.; This is a spontaneous report from a contactable healthcare professional (patient). A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Left Arm on 19Feb2021 11:30 (at the age of 34-years-old) (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient had no medical history. The patient had no known allergies. The patient was not pregnant. Concomitant medications were not reported. The patient received first dose of bnt162b2 for covid-19 immunisation on 29Jan2021. There were no other vaccine in four weeks. On 21Feb2021 18:00, within 48 hours, the patient started to develop rash on temple area of face spread throughout face with swelling and small pumps (as reported), it was also very warm to touch and ears were very hot/red and itchy.  Patient also developed itchy hives in right wrist area and around both knees. The patient did not have covid prior vaccination and was not covid tested post vaccination. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment for the events included steroid shot. Outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
About two days after the patient received her COVID-19 second dose she started experiencing rashes all over her body. She explained the rashes were bright red in appearance and itchy. At first they resembled hives/shingles spots. The location of the bright red rashes were all over her left and right arm, her breast, chest, back, stomach, and pelvis. Hydrocortisone and liquid Benadryl was used to stop the itching but did not make the spots go away. Spots she scratched left brown marks on her body.