chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initially  - VERY severe flu response for 8  hours.  then moderate flu response for 24 hours.  Very painful/sore muscles thoughout body  After that develop a painful scaly rash through upper torso,  Initially diagnosed as fungal infection, but unresponsive to treatment.  Biopsied and diagnosed as psoriasis, but also unresponsive to treatment.  By this time entire body was itching including ears and genitals.  Also eyes became very inflamed both around the eye and in the eye.  Agian, unresponsive to treament.  Finally disagsnosed as PRP  Pityriasis Rubra Pilaris  Initially respnd well to metho trexate but in last 3 weeks sy,ptoms are returning.. Can get mild symptom relief by taking methotexate, prednisolone, OTC pain med ications, and OTC  allergy meds.
Husband put her to bed on 2/19/2021 and she was fine.  Found her later that evening on the floor of the bathroom deceased.
Information has been received from a health care worker concerning a patient who on 13-SEP-2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 649981/0704P or 650451/0750P). On 15-SEP-2005 the patient was seen by a physician, after developing a local reaction described as a large swollen painful area in left arm at site of injection down to forearm. The patient was placed on Keflex and Domboro soaks. At the time of the report the patient was in the process of treatment. No product quality complaint involved. The reporter considered the patient's local reaction, "larger swollen painful are in left arm at site of injection down to forearm" to be an other important medical event (OMIC). Additional information has been requested.
Pt was given a pediatric Pfizer covid vaccine. Should have received an infant Moderna covid vaccine.
Pt developed hives 2 days after infection and lips "felt a little swollen". This was not the patient's first flu shot and usually gets flu vaccines every year. Pt self-treated treated with single dose of  Benadryl with complete resolution of swollen lips- was seen at medical clinic the following morning with hive-like rash on torso and arms. Pt was advised to continue Benadryl and f/u with ER if symptoms worsen.
Clot in his Heart due to the Vaccine; A small Bubble in the Injection site; This spontaneous case was reported by a consumer and describes the occurrence of INTRACARDIAC THROMBUS (Clot in his Heart due to the Vaccine) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 092D21A and 059E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, the patient experienced APPLICATION SITE VESICLES (A small Bubble in the Injection site). On 06-Sep-2021, the patient experienced INTRACARDIAC THROMBUS (Clot in his Heart due to the Vaccine) (seriousness criteria death and medically significant). The patient died on 06-Sep-2021. The reported cause of death was clot in his heart due to the vaccine. It is unknown if an autopsy was performed. At the time of death, APPLICATION SITE VESICLES (A small Bubble in the Injection site) outcome was unknown.            Concomitant product use was not provided by the reporter.  The patient died in his sleep after 24 hours of getting his second dose of the Moderna Covid-19 vaccine. The patient did not have any existing medical condition and the cause of death indicated on death certificate was a clot in his heart due to the vaccine. Patient only had a small bubble in the injection site.  No treatment information was provided.  Company comment: This fatal case concerns a 74-year-old male patient with no medical history reported, who experienced the serious unexpected event Intracardiac thrombosis .The event occurred approximately 28 days after the first dose and one day after the second and most recent dose of mRNA-1273 Moderna vaccine. The reported cause of death was clot in his heart due to the vaccine. It is unknown if an autopsy was performed. Further information has been requested. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Sender's Comments: This fatal case concerns a 74-year-old male patient with no medical history reported, who experienced the serious unexpected event Intracardiac thrombosis .The event occurred approximately 28 days after the first dose and one day after the second and most recent dose of mRNA-1273 Moderna vaccine. The reported cause of death was clot in his heart due to the vaccine. It is unknown if an autopsy was performed. Further information has been requested. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Reported Cause(s) of Death: Clot in his Heart due to the Vaccine
This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Felt sick) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Felt sick) and CHILLS (Chills). At the time of the report, MALAISE (Felt sick) and CHILLS (Chills) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medications were reported. No treatment information was provided. Reporter did not allow further contact
SADDLE PULMONARY EMBOLISM 4/26/2023 ACUTE PULMONARY EMBOLISM  ACUTE PULMONARY EMBOLISM 4/27/2023 ACUTE PULMONARY EMBOLISM
Janssen COVID-19 Vaccine EUA Around 7 hours after receiving the vaccine, began experiencing chills which worsened over a few hours.  Experienced sweats, joint pain, light headedness, nausea, and numbness in face and fingers.  All symptoms but numbness lasted for around 14 hours.  Numbness was off and on.  After 14 hours only experiencing achy joints, head ache, fatigue, weakness.  Took Tylenol when experiencing the worst symptoms.
FAINTED AFTER FIVE MINUTES AFTER RECEIVING VACCINE. LAYED ON FLOOR. CALLED 911.
This case was reported by a nurse practitioner and described the occurrence of a raised red rash in a 60 year old female patient who received Hep-B vaccine.    Concurrently the patient received no other medications.  The patient also reported no known drug allergies  On 21 SEP 2004 the patient received an application of tuberculin purified protein derivative.  The tuberculin test was examined on 23 SEP 2004 with negative results reported.  On 23 SEP 2004 the patient received the first dose of Energix-B.  Approximately seven days later, on 30 SEP 2004 the patient experienced a raided rash on both forearms and both shins. The patient was seen by a nurse practitioner and was treated with topical cortisone.  The immunization series with Energix-B was discontinued.  The rash had improved by 26 Nov 2004.  The nurse practitioner considered the event to be possibly related to vaccination with Energix-B.
Administered 2nd dose of Moderna Covid19 vaccination in L deltoid muscle. Approx. 10 minutes later, client reported that she felt heaviness in her chest and that her head hurt badly. Notified EMS that were on-scene of client's condition.
At a very rapid pace, I went from healthy & strong to losing use of arms (pain/weakness), legs (weakness), shoulder/neck/arm/hand extreme pain/burning. Dropped 30 pounds in 3 mos. and bedridden w/in 2 mos. Surgery on spine (fused several vertebra) eventually to find answer & relief. 2-3 year rehab. to gain upper body muscle & weight lost in 3 mos.  Continued chronic pain & shoulder/neck/arm/hand pain and weakness.
Pt received vaccine on 9-21-18, PNEUMOVAX and FLUZONE QUAD. In the evening, she had pain in the Right arm, tenderness. Swelling on the next day. By Sunday afternoon she went to ER. She felt nauseous headache.w/BENADRYL/ice pack - ER gave her Cephalosporin and released the same day. But she feels better.
Inappropriate dose of vaccine administered (Incorrect dose administered). A non-serious spontaneous report gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician form CDC reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that one of the children experienced adverse events.
Vaccination Adverse Reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination Adverse Reaction) in a 47-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced IMMUNISATION REACTION (Vaccination Adverse Reaction). At the time of the report, IMMUNISATION REACTION (Vaccination Adverse Reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment medication was not reported.  The Index number was reported as UN-09299.   Reporter did not allow further contact
patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On 27-Oct-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Vaccines were not frozen at time of administration. Vials only punctured right before administration - during COVID-19 vaccine clinic all doses were drawn from vial due to high-pace clinic. On 27-Oct-2021, Excursion time was 9 AM, temp was 29 , Excursion time was 10 AM, temp was 32 total doses given for the day was 116, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 03-Nov-2021. 6 vial was moved to clinic. Vaccine BUD date was 29-Oct-2021 and 04-Nov-2021. Vials only punctured right before administration Fisherbrand traceable temperature monitor was used to record hourly temperatures. It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medication were not reported.
Local swelling at site of injection and pain. Advice cold compresses and Tylenol PRN.
arm got hot; arm got itchy; rash; Swollen; red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm got hot), VACCINATION SITE PRURITUS (arm got itchy), VACCINATION SITE RASH (rash), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (red) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     The patient's past medical history included Hyperlipidemia (high cholesterol). Concurrent medical conditions included Drug allergy (ciloxin) and Allergy (airbone pollutants). Concomitant products included SIMVASTATIN and LORATADINE.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE WARMTH (arm got hot), VACCINATION SITE PRURITUS (arm got itchy), VACCINATION SITE RASH (rash), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE WARMTH (arm got hot), VACCINATION SITE PRURITUS (arm got itchy), VACCINATION SITE RASH (rash), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up received on 23-06-2021 contains No significant information
WOKE UP SWEATING; BODY SORENESS; CHILLS; HEADACHE; FEVER; THREW UP ABOUT EIGHT TIMES; TROUBLE BREATHING; This spontaneous report received from a parent concerned a 19 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported.  On 10-APR-2021, the subject experienced threw up about eight times. On 10-APR-2021, the subject experienced trouble breathing. On 10-APR-2021, the subject experienced body soreness. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced woke up sweating.  Laboratory data included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from threw up about eight times, trouble breathing, chills, and fever on 11-APR-2021, and woke up sweating on 12-APR-2021, was recovering from body soreness, and had not recovered from headache. This report was non-serious.
I have developed Polycythemia vera which is I have high red blood cells; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: ER2613) and as dose 2, single (Lot number: ER8731) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: POLYCYTHAEMIA VERA (medically significant), outcome "unknown", described as "I have developed Polycythemia vera which is I have high red blood cells".  No follow-up attempts are possible. No further information is expected.
She had a stroke on 3/28/2021 due to a blood clot in her brain; She had a stroke on 3/28/2021 due to a blood clot in her brain; Administration_date=08/03/2021 number=1/administration_date=22/03/2021 number=2; Administration_date=08/03/2021 number=1/administration_date=22/03/2021 number=2; This is a spontaneous report from a contactable consumer reporting for herself. A 66-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Unknown), via an unspecified route of administration, administered in Arm Right on 22Mar2021 17:45 (vaccinated at the age of 66 years old) as single dose for covid-19 immunisation. Patient received the first dose on 08Mar2021. Medical history included diabetes; obesity; high blood pressure, iodine allergy. The patient's concomitant medications were not reported. The patient experienced she had a stroke due to a blood clot in her brain on 28Mar2021 18:30, The patient was hospitalized for she had a stroke due to a blood clot in her brain (cerebrovascular accident) for 2 days. Patient visited Emergency room/department or urgent care for events a stroke due to a blood clot in her brain and received treatment. Outcome of event a stroke due to a blood clot in her brain was not recovered.   Information about lot/batch number requested.
Numbness and tingling in three middle fingers of the left hand. Has continued on and off daily.
Extreme headache, dizziness, feeling of disconnection from limbs, unexplained body pain, all within hours of receiving vaccine. Reported to EAP and told vaccine did not and would not cause these issues so soon. Referral sent to neurology and cat scan preformed. Midrin prescribed for headaches and pain. Never had headaches or issues before vaccine. Still have issues with all symptoms nearly 7 years later.
Received the 2nd dose of Moderna vaccine and would like to participate in Pregnancy Registry; Injection arm soreness (left arm ); This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received the 2nd dose of Moderna vaccine and would like to participate in Pregnancy Registry) and VACCINATION SITE PAIN (Injection arm soreness (left arm )) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 044A21A) for COVID-19 vaccination.     No medical history were reported.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 22-Dec-2020 and the estimated date of delivery was 28-Sep-2021. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (Injection arm soreness (left arm )). On 30-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received the 2nd dose of Moderna vaccine and would like to participate in Pregnancy Registry). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy.  On 30-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Received the 2nd dose of Moderna vaccine and would like to participate in Pregnancy Registry) had resolved. At the time of the report, VACCINATION SITE PAIN (Injection arm soreness (left arm )) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No treatment medication were reported.
Moderna COVID-19 Vaccine EUA.  Intense arm pain in the deltoid muscle for a few days. Two months later, occasional ongoing deltoid pain. Additionally, a rash appeared on the left deltoid 7 days after the vaccine. Resolved in 3-4 days.
Lot of hair loss; This is a spontaneous report received from a contactable consumer (patient husband). An elderly (reported Age: 77; Unit: Unknown) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 20Jan2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Jan2021, 7-10 days after the first vaccine, started experiencing lot of hair loss. Reporter wanted to know if it was reported in the clinical trials for the vaccine and strongly suspects that it was related to the vaccine. Patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on unspecified date as single dose for covid-19 immunisation. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
The patient developed light-headedness, hypotension and a transient rash at the site of vaccination immediately after receiving a Td vaccination while in the doctor's office.  The doctor administered IV fluids, and the patient recovered.
Injection site rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Injection site rash) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.     On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE RASH (Injection site rash). On 10-Feb-2021, VACCINATION SITE RASH (Injection site rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-034398 (Patient Link).
Moderna COVID-19 Vaccine EUA  Hard , reddened area at injection site.  Sore to touch. Fever Muscle aches Headaches Chills Fatigue All lasted 2 days
Flu-like symptoms: fever, chills, general aches.  Came home from work early, took acetaminophen, took a nap for a few hours.  Temperature after nap was 100.4 (I did not measure before)
There was not an adverse event. The dose was give at 1 yr old which is 3-6 mo earlier than recommended.