chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: 72 yo M died on 4/23/2021 wit History of hepatitis C with successful treatment approximately 10 years ago. He had some abdominal swelling and fullness and ultrasound CT and MRI demonstrated a dramatically locally advanced as well as widely metastatic central liver tumor per 4/14/21 PCP note. Pt was still in diagnosis phase of treatment prior to death on 4/23/21 at outside facility. Pt received covid vaccinations at outide facility on 2/17/21 & 3/18/21. Pt's death likely not related to death given recent advanced liver cancer diagnosis prior to death.
localized bruised @ inj site lt deltoid approx 35cm by 35cm;entire upper lt arm redness, swelling & soreness times 2wk;tx heating pad;
Information has been received from a nurse, referring to a 68 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 06-OCT-2017, the patient was vaccinated with a dose of VARIVAX lot # N017700, with expiration date on 09-JUN-2019 (strength, anatomical location and administration route were not reported) for prophylaxis instead of ZOSTAVAX. The reporting nurse stated that the reason for giving VARIVAX was a human error. No adverse effect were reported.
Rash extending from elbow to hand; Itchy sensation on left arm; Rash on the left arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash extending from elbow to hand), VACCINATION SITE PRURITUS (Itchy sensation on left arm) and VACCINATION SITE RASH (Rash on the left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seafood allergy.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced RASH (Rash extending from elbow to hand), VACCINATION SITE PRURITUS (Itchy sensation on left arm) and VACCINATION SITE RASH (Rash on the left arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH (Rash extending from elbow to hand), VACCINATION SITE PRURITUS (Itchy sensation on left arm) and VACCINATION SITE RASH (Rash on the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
Initial health care professional report received on 10 Mar 2010: This patient received expired FLUVIRIN, 0.5ml intramuscular on an unknown date in Mar 2010, sometime between 01 Mar 2010 and 09 Mar 2010. No other adverse events was reported.
The next day, patient had red itchy rash all over the body, itchiness, pain, swelling of feet and hands. Finally, by 9/21/22 she felt almost back to normal.
Chills, red, hot, sore arm, headache, sweats, body aches
I began to have swelling of my lymphnodes and it kept increasing. I then had a bright red hot spot to appear on my left arm. I went to see my docotor first and she gave me some antibiotics. The following day I went back to the center and I was diagnose with a Delayed Hyper Immune Response. She then gave me a presciption for prednisone to stop the reaction.
This spontaneous report was received from the registered nurse regarding a 8 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 08-AUG-2018, the patient was vaccinated with improperly stored VARIVAX lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Mother notified office approx 45 minutes to 1 hour after vaccination that patient was having chills and was shaking.  Denies pain in arm.  Instructed mom to notify pediatrician who was ordering physician.
had a hard nodule on Injection site on the right arm after 2nd booster; had a difficult time completing a sentence speech was greatly affected/speech came back on Saturday, but she was not able to respond clearly to questions; Memory was greatly affected after 2nd booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE NODULE (had a hard nodule on Injection site on the right arm after 2nd booster), SPEECH DISORDER (had a difficult time completing a sentence speech was greatly affected/speech came back on Saturday, but she was not able to respond clearly to questions) and MEMORY IMPAIRMENT (Memory was greatly affected after 2nd booster) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065K21A, 058F21A, 002A21A and 029L201A) for COVID-19 vaccination.     It was reported that patient had excellent medical history, no health concerns. Didn't take any medications or homeopathic medications prior to 2nd booster vaccination.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2022, the patient experienced VACCINATION SITE NODULE (had a hard nodule on Injection site on the right arm after 2nd booster), SPEECH DISORDER (had a difficult time completing a sentence speech was greatly affected/speech came back on Saturday, but she was not able to respond clearly to questions) and MEMORY IMPAIRMENT (Memory was greatly affected after 2nd booster). On 05-Jun-2022, SPEECH DISORDER (had a difficult time completing a sentence speech was greatly affected/speech came back on Saturday, but she was not able to respond clearly to questions) and MEMORY IMPAIRMENT (Memory was greatly affected after 2nd booster) had resolved. At the time of the report, VACCINATION SITE NODULE (had a hard nodule on Injection site on the right arm after 2nd booster) was resolving.            No concomitant medication was reported.  Patient's speech and Memory was greatly affected. Patient speech came back on 04-Jun-2022 (Saturday) but patient was not able to respond clearly to questions. That continued until 05-Jun-2022 (Sunday) evening when memory and clarity came back.  It was also reported that on 07-Jun-2022, the nodule was softening on the right arm injection site.  Treatment details was not reported by the reporter.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 26-OCT-2018, the patient was vaccinated with improperly stored VAQTA (lot # R013859, expiration date 14-JUN-2019) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
rash after first dose, rash turned into bruise with swelling, hot to touch within week after dose; rash after first dose, rash turned into bruise with swelling, hot to touch within week after dose; rash after first dose, rash turned into bruise with swelling, hot to touch within week after dose; rash after first dose, rash turned into bruise with swelling, hot to touch within week after dose; This is a spontaneous report from a contactable consumer. A adult non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if patient was diagnosed with COVID-19, prior to vaccination. On an unspecified date, patient had rash after first dose, rash turned into bruise with swelling, hot to touch within week after dose. No additional treatment for all the events. It was unknown if patient had been tested for COVID-19, since the vaccination. The outcome of all the events was resolved on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Swollen neck/collar bone area. Painful lump.  I tried taking Tylenol for the pain and swelling but it has not gone away. I also tried ice for the swelling and warm compress for the pain.  Lump is still there and painful on a scale from 1-10, its about a 7. The pain is worse at the end of the day.  Been this way since the 6th of January and I thought it was sore due to the shot and the other small issues I had( headache, low grade fever) The pain was not going away after all the other issues did.
I'm 14 and just got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (I'm 14 and just got the vaccine) in a 14-year-old patient of an unknown 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (I'm 14 and just got the vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (I'm 14 and just got the vaccine) outcome was unknown.            No concomitant and treatment medications were reported.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination. No Medical History information was reported. On 28-Feb-2021 at 2:44 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 2:32 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 28-Feb-2021 at 2:44 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F.). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Age of patient was reported as 47.99 for dose administered on 28-Feb-2021 and 48.06 for dose administered on 28-Mar-2021. No concomitant medications were reported. Batch number 014M20A underwent temperature excursion on 28-Feb-2021 with temperature 27 and 26 degrees Fahrenheit from 09:00 AM to 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021. Batch number 019B21A underwent temperature excursion on 28-Mar-2021 with temperature 35 degrees Fahrenheit from 10:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.
very uncomfortable; little cough; head cold; little achiness and headache; chills; bad muscle aches; joint aches; ankles aches; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (little cough), NASOPHARYNGITIS (head cold), DISCOMFORT (very uncomfortable), MYALGIA (bad muscle aches) and ARTHRALGIA (joint aches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included VALSARTAN, OMEPRAZOLE, SERTRALINE, ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA ALLERGY) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced MYALGIA (bad muscle aches) and ARTHRALGIA (joint aches). 20-Feb-2021, the patient experienced ARTHRALGIA (ankles aches). On 21-Feb-2021, the patient experienced CHILLS (chills). On 22-Feb-2021, the patient experienced COUGH (little cough), NASOPHARYNGITIS (head cold) and HEADACHE (little achiness and headache). On 23-Feb-2021, the patient experienced DISCOMFORT (very uncomfortable). At the time of the report, COUGH (little cough), NASOPHARYNGITIS (head cold), DISCOMFORT (very uncomfortable), MYALGIA (bad muscle aches), ARTHRALGIA (joint aches), ARTHRALGIA (ankles aches), HEADACHE (little achiness and headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Approximately 7 hours after receiving the vaccine, I had severe muscle aches throughout my body, and headache, fever and chills.
Started to hurt just like any other shot. Never subsided. That night and continuing, I could not sleep on that side. My daughter, who got a shot at the same time, called me on 3/12/2021 to see if I had a rash like she did, so I went and looked in mirror. Rash from  shoulder to almost elbow. I called  today and sent photo.
Vaccine given to child under age of  18 years. At this point no sxs. Called and spoke with father and he VU. I will follow up again on this case.
I presented seven days after getting the vaccine with colitis. I was treated with intravenous antibiotics for four days. They did a CT scan of my abdomen they also found two cyst on my pancreas. I was referred a gastroenterologist for the ipmn pancreas I will know more once I see him. I do feel better.
Fever 102 for about two days followed by many papules, few blisters and finally few ulcers over the next 6 days. In total about 25-30 ulcers over his body.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old patient received BNT162b2 (BNT162B2), on 18Jan2021 at 08:30 as dose 1, single (Lot number: EL1283), in left arm, on 08Feb2021 at 08:30 as dose 2, single (Lot number: EM9809), in left arm, on 04Oct2021 at 10:00 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 11Apr2022 at 11:00 as dose 4 (booster), single (Lot number: FJ9943) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure (controlled)" (unspecified if ongoing), notes: High blood pressure (controlled). The patient's concomitant medications were not reported. Past drug history included: O, reaction(s): "O drug allergy".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. This report was about COVID-19 treatment. Patient did receive the vaccine. Patient received treatment for COVID-19 as Paxlovid from 07Jun2022 to 11Jun2022. Seriousness criteria was reported as no for Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.
Drooping eyelids; swelling in neck on both sides; swelling of both eyelids; Skin on neck appears pink; Light headedness; SKIN ON NECK APPEARS PINK; Headache; Fatigue; face swollen on right side; This spontaneous case was reported by a consumer and describes the occurrence of EYELID THICKENING (Drooping eyelids), SWELLING (swelling in neck on both sides), SWELLING OF EYELID (swelling of both eyelids), SKIN DISCOLOURATION (Skin on neck appears pink) and DIZZINESS (Light headedness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced SWELLING FACE (face swollen on right side), HEADACHE (Headache) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced EYELID THICKENING (Drooping eyelids), SWELLING (swelling in neck on both sides), SWELLING OF EYELID (swelling of both eyelids), SKIN DISCOLOURATION (Skin on neck appears pink), DIZZINESS (Light headedness) and RASH (SKIN ON NECK APPEARS PINK). The patient was treated with PREDNISONE at a dose of 1 dosage form. On 31-Jan-2021, HEADACHE (Headache) and FATIGUE (Fatigue) had resolved. At the time of the report, EYELID THICKENING (Drooping eyelids), SWELLING (swelling in neck on both sides), SWELLING OF EYELID (swelling of both eyelids), SKIN DISCOLOURATION (Skin on neck appears pink), DIZZINESS (Light headedness), SWELLING FACE (face swollen on right side) and RASH (SKIN ON NECK APPEARS PINK) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had a teladoc appointment with their HCP. The HCP prescribed prednisone for three days. According to the patient, the HCP could not make a determination whether the reaction was related to the vaccine or something else   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Non significant follow up received
After receiving the vaccine, client verbalized she feels hot and sweaty.  Client was evaluated by Fire Rescue on site.  Client's symptoms resolved and released to go home per Fire Rescue at 10:28 am.
itchiness at injection site; redness at injection site; raised spot at injection site; This spontaneous case was reported by a consumer and describes the occurrence of   in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 20-Jan-2021, the patient experienced itchiness, redness and a raised spot at injection site. Concomitant medications were not provided. The patient did not receive any treatment medications.
Information has been received from a registered nurse concerning a 57 year old white female with no known drug allergies, who on 30-APR-2008, was vaccinated at a pharmacy with a dose of ZOSTAVAX. Concomitant therapy included ACTONEL, ALLEGRA-D, LIPITOR, calcium (unspecified), omega-3 marine triglycerides, montelukast sodium, PLAQUENIL and amitriptyline. On 05-MAY-2008, the patient broke out in chickenpox. "Today", on 07-MAY-2008, the patient was seen at the physician's office and was covered with varicella "head to toe", felt miserable and had a low grade fever. The patient was being treated with VALTREX. The patient's chickenpox persisted. No product quality complaint was involved. The registered nurse considered chickenpox to be disabling. Additional information has been requested.
Patient received flu shot 9:30 AM.  States within hours had rash, upset stomach, fever.  Patient called hospital, spoke with someone on phone - patient seeing doctor, taking Amoxicillin for ear infection.  No fever - patient seen at hospital 11/18/08 2:10 pm.  Patient will follow up with primary MD if symptoms reoccur or if she does not continue to improve.
Fatigue started 4/6/2021 then on 4/7/2021 upper right arm was very sore and hot to the touch. Soreness extended down arm and lasted most of the day on 4/7/2021. About 2pm I took 2 Tylenol and that started to minimize the ache, by bedtime my arm felt better.
PT TESTED POSITIVE FOR COVID BEFORE BEING DISCHARGED FROM THE HOSPITAL  - Admission Discharged  5/3/2021 - 5/28/2021 (25 days) Last attending ? Treatment team Diverticular stricture (CMS/HCC) Principal problem BRIEF OVERVIEW Admitting Provider:  MD Discharge Provider: CRNP Primary Care Physician at Discharge:  MD   Admission Date: 5/3/2021     Discharge Date: 5/28/2021 Hospital Problems        POA    * (Principal) Diverticular stricture (CMS/HCC) Yes         Colonic obstruction (CMS/HCC)       MSW Social Worker Plan of Care    Addendum Date of Service:  5/28/2021 10:34 AM     Addendum        Hide copied text  for details LTAC able to take pt today and pt is stable for d/c. COVID test ordered. Results not needed prior to d/c. Per  at Clinic, pt is able to go after noon today. Working on transportation time. SW updated pt's dtr on plan and she is in agreement. 10:36 AM    Pt's COVID test came back positive. Transportation cancelled. Care team notified. 1:57 PM    LTAC aware of COVID positive status. They are still able to admit pt. Working on getting transportation back. 2:26 PM   Transportation coming back. Confirmed with Dr team that pt is stable for d/c even with COVID positive status. 2:32 PM