chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 06-OCT-2010, the patient was inoculated at a medical center/hospital with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 16-SEP-2015, the patient was treated by the medical center/hospital for a blistering vesicular outbreak which was diagnosed as ocular shingles. The patient was prescribed codeine for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Upon internal review, persistent strain condition of herpes zoster/ blistering vesicular outbreak, which was diagnosed as ocular shingles was determined to be a medically significant event. Additional information has been requested.
Patient presented to the hospital with AMS. Patient is poor historian, HPI obtained from patient daughter and EMR. Long-term nursing home resident. Patient had been diagnosed with Covid-19 the previous week. Patient was becoming more confused at nursing home. Patient was noted to have severe UTI with sepsis. Patient diagnosed with pneumonia due to Covid-19 virus, acute metabolic encephalopathy likely secondary due to dementia, sepsis, UTI and Covid-19. Chest xray showed bilateral infiltrates. Patient was on 3L NC, received antibiotics. Patient was discharged back to nursing home.
At approximately 15 minutes post vaccine patient reported left hand numbness/tingling.  At about 30 minutes patient reported lip tingling, given 25 mg benadryl.  Shortly progressed to "heart pounding" and progressing  "facial tingling and throat tightening".  Epipen 0.3mg administered and EMS called.  Pt reported feeling much better within 2-3 minutes of epi pen.  Transported to  Hospital for further care.
Rash at injection site on L arm started 7/11/17. No other symptoms. On 7/12/17 rash spread over whole body sparing neck and head with behind the knees worse. Fever of 100. No pain or SOB.
Moderna COVID-19 Vaccine EUA patient developed acute respiratory failure with bilateral pulmonary infiltrates 1 week after receiving Moderna COVID vaccine
This case is associate with 2013SA102511. Initial report received from consumer or other non HCP on 26 November 2013. A unknown-year-old female patient whose medical history and concomitant medications were not reported received FLU VACCINE (lot number unknown and expiration date unknown) (route, site and dose number not reported) on 05 October 2013. On an unknown date, the patient felt bad. Laboratory investigation and corrective treatment were not reported. As of this report, the event outcome was unknown. Documents held by sender: none.
Patient received the Pfizer COVID vaccine on 7/27/2021. When the patient presented for her second Pfizer COVID vaccine on 8/23/2021, she was given the Moderna COVID vaccine in error.
Client begin complaining of back and leg pain in both legs on 8/12/10. Rash developed under left eye with redness of left eye on 8/12/10 - Rash then developed under right eye on 8/13/10. Mother gave BENADRYL which seemed to clear up the rash. Child was seen by Dr. at the Center on 8/13/10- Pain and rash subsided by 8/15/10. Only BENADRYL and TYLENOL were given. Mother states child is back to normal as of 8/16/10.
breast cancer; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 23Mar2021 (Batch/Lot Number: EN6204) as dose 2, single (at the age of 68 years-old) for COVID-19 immunisation; varenicline tartrate (CHANTIX), via an unspecified route of administration from May2020 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose, then via an unspecified route of administration from Apr2021 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose, then via an unspecified route of administration from an unspecified date (Batch/Lot Number: EM4807; Expiration Date: Jun2023) to an unspecified date, at 1 mg (1 mg for 4 weeks, 56 tablets) for smoking cessation therapy.  Medical history was unknown. There were no concomitant medications.  The patient previously received bnt162b2, dose 1 via an unspecified route of administration, administered in the left arm on 05Mar2021 (Batch/Lot Number: EN6205) as dose 1, single (at the age of 68 years-old) for COVID-19 immunisation. The patient experienced breast cancer on an unknown date in 2021.  The clinical course is as follows: the patient went to get her annual mammogram, they asked if she had a COVID vaccine and she said yes, she has had both doses of the Pfizer COVID vaccine in her left arm. She had another mammogram and a biopsy and it was cancer, the patient had to have a lumpectomy. The patient stated she thought that what was odd is that she got her shots in her left arm and it is her left breast where the cancer shows. The patient stated the cancer was in the very beginning stages, and the patient will be undergoing radiation. The patient reported that no one in her family has had breast cancer and they don't know why she got it. Therapeutic measure were taken as a result of the event and included lumpectomy, surgery and radiation. The patient underwent lab tests and procedures on an unknown date in 2021 which included biopsy: it was cancer, mammogram: unknown results, and additional mammogram: it was cancer. The action taken in response to the event for varenicline tartrate was unknown. The clinical outcome of the event breast cancer was unknown.
Isolated axillary fossa swelling in arm that received vaccine. This was fluid/effusion. No apparent adenopathy. Fluid not assessed. Resolved after 3 days spontaneously, no treatment needed.
Mother states client began running fever 11/7/07 at night. Grade of fever unknown b/c mother states they do not have thermometer. Client had decreased appetite11/7/07 PM as well. Reports giving Tylenol and alternating with Motrin q 6 hours beginning 11/7/07. States 11/8/07 went to school and was "fine", no fever. She ate good that night but again ran fever at night and gave Tylenol, alternating with Motrin q 6 hrs. States a "red splotchy" rash.
I had my vaccination on 11/17/2022. In 02/2023 I started to experience pain in shoulders bilaterally mostly in my right shoulder. This pain has been ongoing and has gotten progressively worse. I contacted my physical in 04/03/2023. I was prescribed physical therapy in my shoulder. I am to go back for a steroid shot for the pain if the physical therapy does not improve the pain in my shoulder.
Had "fullness", "heaviness" in chest, tiredness in left arm from fingers to neck. Left arm slightly swollen. Fullness went also down to left thigh on 10/14/2009. On 10/15/2009 temp 99. Still had tightness in left arm for 3 weeks.
Patient was given a DTaP on 03-12-2008. Patient seen in office on 03-19-2008 with 4cm X 6cm redness and mild swelling on Left deltoid.
Patient developed a rash (possible hives) on her abdomen, legs, and arms. Patient also had a fever of 101.6F and did not sleep well that night.
fever 104.0, pain, warmth @ site, chills, these sx lasted 6 days;
Sleepy; tired and sleeps a lot; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy) and FATIGUE (tired and sleeps a lot) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included TAMSULOSIN, LISINOPRIL, GABAPENTIN, HYDROCODONE, ATORVASTATIN, VITAMIN C [ASCORBIC ACID], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), ACETYLSALICYLIC ACID (ASPIRIN LOW), IRON and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced SOMNOLENCE (Sleepy) and FATIGUE (tired and sleeps a lot). At the time of the report, SOMNOLENCE (Sleepy) and FATIGUE (tired and sleeps a lot) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medicines include  Tamsulosin lisinopril, gabapentin, hydrocodone, atorvastin, vitaminC vitaminB12, l ow dose aspirin, iron, prenatal vitamin  Treatment drugs were not provided  Action taken with mRNA-1273 in response to the event was not applicable.
pt recv vax 19DEC97 330AM & 730AM & separate sz; T40C @ time gen tonic-clonic sz lasting approx 2min;pt seen @ urgent care 8AM later seen in office & sent to ER;
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (had a tender left arm/Tender left injection site arm) and FATIGUE (patient was tired the next day after second moderna vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (had a tender left arm/Tender left injection site arm) and FATIGUE (patient was tired the next day after second moderna vaccine). At the time of the report, VACCINATION SITE PAIN (had a tender left arm/Tender left injection site arm) and FATIGUE (patient was tired the next day after second moderna vaccine) outcome was unknown.            Concomitant medication not provided by reporter. Treatment information not provided by reporter.   This case was linked to MOD-2021-293330, MOD-2021-293338 (Patient Link).
Information has been received from a physician concerning a 72 year old female with diabetes, asthma and osteoporosis who on 02-JAN-2008 was vaccinated SQ with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (lot # 659150/1384U). Concomitant therapy included NORVASC, GLUCOPHAGE, ezetimibe (+) simvastatin (MSD), ECOTRIN and ALTACE. On 03-JAN-2008, the patient experienced swelling, redness and pain at the injection site. Medical attention was sought. The patient was treated with BENADRYL. At the time of the report, the patient was recovering. Additional information has been requested.
Ringing in both ears. Its started after my 1st vaccination in April 2021, its grew louder after my 2nd vaccination in March 2021. I was referred to an audiologist by my Doctor. I was basically told that it might disappear as suddenly a it appeared and to keep updating my Doctor. I was able to ignore it for the most part although it became bothersome in the evening.  There was no noticeable change after my 3rd vaccination in October 2021, however it got "louder" after the 4th in April 2022. I have advised my Doctor of this and we are discussing the possibility of a 2bd referral.
**Note: Manufacturer is actually Sanofi Aventis.  Patient noticed hives on her chest same day she received the shot.  Patient took Benadryl.  Next morning, patient had welted red rash all over chest, thighs, stomach and back.  Went to urgent care and given antihistamines and steroids.
Her back began to hurt.; Headache; fever ~101.5; chills; muscle aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2022 at 11:00 as dose 4 (booster) single (Batch/Lot number: unknown) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose:1), for COVID-19 Immunization; Bnt162b2 (dose:2), for COVID-19 Immunization; Bnt162b2 (dose:3), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 08Apr2022 at 19:00, outcome "recovered" (09Apr2022); BACK PAIN (non-serious) with onset 08Apr2022 at 19:00, outcome "recovered" (09Apr2022), described as "Her back began to hurt."; CHILLS (non-serious) with onset 08Apr2022 at 19:00, outcome "recovered" (09Apr2022); PYREXIA (non-serious) with onset 08Apr2022 at 19:00, outcome "recovered" (09Apr2022), described as "fever ~101.5"; MYALGIA (non-serious) with onset 08Apr2022 at 19:00, outcome "recovered" (09Apr2022), described as "muscle aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of back pain, headache, pyrexia, chills, myalgia.  Additional information: Dose received More than 3. Around 7 pm on Friday 08Apr her back began to hurt. Later in the evening a headache started and she ran a fever 101.5, had chills and had muscle aches. This lasted until Saturday afternoon. Unknown If COVID prior vaccination. Unknown If COVID tested post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pancreatitis which was found on 9/4/22 with CT scan of abdomen; mild case - resolved with 24 h liquid diet with 72 hrs of soft diet
PT IS NURSE AT OUR HOSPITAL, CAME TO INF. CONTROL FOR INFLUENZA VACCINE AT 1300.  REC'D VACCINE WHICH SHE HAS TAKEN EVERY YEAR FOR THE LAST 4-5 YEARS AND NEVER HAD A PROBLEM. APPROX. 5-10 MINUTES AFTER GETTING THE SHOT SHE REPORTED TO A COWORKER THAT SHE "WAS HAVING TROUBLE GETTING HER BREATH.  tHE COWORKER BROUGHT HER TO THE ER IMMEDIATELY WHERE SHE WAS FOUND TO BE IN EXTREME RESP. DISTRESS WITH AUDIBLE WHEEZING AND AN INITIAL OXYGEN SAT OF 85%.  SHE WAS TREATED WITH CONTINUOUS NEBULIZERS, XOPENEX (SHE TOOK 4 PUFFS FROM HER MDI ENROUTE TO ER), ALBUTEROL AND RACEMIC EPINEPHRINE.  SHE REC'D 0.4 EPINEPHRINE SUB Q AND SOLUMEDROL 250MG IV.  SHE IMPROVED SOMEWHAT BUT HAD TO TRANSFERRED TO A PULMONOLOGIST AND AN ALLERGIST.  THEY BOTH TOLD HER THEY BELIEVED THE REACTION WAS FROM THE FLU SHOT--NOT HER ASTHMA.  SHE IS A NEWLY DIAGNOSED ASTHMATIC AND WAS HOSP. ABOUT 2 MOS PRIOR TO VACCINATION WITH ASTHMA. INCIDENTLY, SHE HAD STOPPED TAKING HER SINGULAIR ABOUT ONE WEEK PRIOR TO VACCINATION AS ORDERED.
employees were vaccinated from a vial that was punctured more than 6 hours ago; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 Vaccine and who experienced an expired product administered.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 22 Dec 2020, a vial containing the Moderna COVID-19 vaccine was punctured.  Instead of being discarded, the vial was placed in cold storage.  On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (LOT number 011J20A) for prophylaxis of COVID-19 infection.   On 27 Dec 2020, the nurse reported that the patient had received the mRNA-1273 vaccine from the vial that was punctured more than 6 hours before administration.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The event, expired product administered, was considered resolved on 23 Dec 2020.; Reporter's Comments: This case concerns an unidentified patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Expired product administered without any associated adverse events.
Experienced lightheadness and severe weakness causing patient to sit down on ground at gas station.  Attendant called 911 and transported to hospital via ambulance.  Had vitals taken but left ER after 2 1/2 hr wait to see Dr. as "feeling better". Once home, during the night developed severe leg cramps with spasms in feet and knees. On 12/2 experienced mild nausea with some lightheadness but developed severe headache during the day. Called today 12/3 as currently experiencing nausea, loose stools (X3).  Headache has subsided but lightheadness continues and is not affected by change in position.  Has panic attacks and takes Klonopin for treatment.  Took a dose today.
Cardiology provider wanted to report that patient experienced an acute CHF exacerbation within 1-3 weeks after vaccine administration.  Admitted to hospital for IV diureses.
passed out when outside.  This is the same day his sister passed out. His twin was admitted with myocarditis.
immune system's reaction; flare ups after vaccination; This is a spontaneous report received from a contactable consumer, the patient. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) as 1st dose, single, dose 2 via an unspecified route of administration on 30Apr2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient reported that he was experiencing flare ups after vaccination. The patient stated that his doctor stated that this normal and was immune system's reaction and will go away in about a month. The patient stated that it was getting better over time. Pharmacist informed the patient that it will get better with the more doses of Dupixent given and symptoms should be resolved eventually, but as far as a time frame couldn't tell exactly. The outcome of the events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Client received the [1st] COVID vaccine (Pfizer lot #EW0171 and expiration date: 04/24/21) at 2:54pm to right arm. At 9:47 am RN reported that client was reporting symptoms in Spanish that she could not translate. Other RN responded and provided Spanish translation. Client sitting in observation chair complaining of symptoms which she described as heaviness in her tongue and neck pain. Other RN instructed EMT to take client to observation room and lay her in semi-fowler's position. Other RN presented to observation area and requested VS. Client denies shortness of breath, chest pain, itchiness, swelling in other areas of body, hives, or rash. Client denies allergies or medical history. Denies taking medications at this time. Client is alert and oriented to place, time, and date. VS at 9:58 am HR 97, SpO2 95% RA, BP 198/119. Other RN activated emergency number. Paramedics assumed care at 10:05am. Client transported to Hospital. Client's husband alerted of transportation to hospital by other RN.
Itching at injection site; Moderna 1st dose: 10-Sep-2021 and 2nd Dose: 01-Oct-2021; Suspected COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itching at injection site), SUSPECTED COVID-19 (Suspected COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 1st dose: 10-Sep-2021 and 2nd Dose: 01-Oct-2021) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    The patient's past medical history included Chronic kidney disease stage 4 in 2019, Thoracic vertebral fracture T11 in 2011, Gout in 2020, Reduced general condition (nothing to do with her medication) in 2019, COVID-19 in November 2019 and Intraocular lens replacement in 2019. Concurrent medical conditions included Chronic kidney disease stage 3 since 29-Oct-2021 and Rheumatoid arthritis.   On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous)  In 2021, the patient experienced SUSPECTED COVID-19 (Suspected COVID-19). On 01-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 1st dose: 10-Sep-2021 and 2nd Dose: 01-Oct-2021). On an unknown date, the patient experienced INJECTION SITE PRURITUS (Itching at injection site). At the time of the report, INJECTION SITE PRURITUS (Itching at injection site), SUSPECTED COVID-19 (Suspected COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 1st dose: 10-Sep-2021 and 2nd Dose: 01-Oct-2021) outcome was unknown.            No concomitant medication was reported.  Patient had rheumatoid arthritis and other two issue had her body tried to give up. On an unknown date, patient had another issue. When patient took both COVID vaccines, patient got all the COVID symptoms. Patient reported other than injection site reaction she had no issues. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was reported.  The reporter causality for COVID symptoms, itching at injection site with co-suspect Humira was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
At site of flu shot pt has red, hot, hard lump 5 days after administration.
Aching and painful Joints starting with shoulders proceeding down body affecting hands and hips.  Becoming so painful and causing stiffness that felt like I was having an arthritis attack and sought out doctor's care.
One week following my first dose of Moderna I developed shingles on my right eye and forehead.  It was treated within 48 hours of onset of the classic type symptoms of shingles with valacyclovir for 7 days. The condition improved over  the one week course of treatment with lesions almost gone by 8th day after onset.
exhaustion, also my period started 2.5 weeks early after it just ended 9 days ago.
Patient Developed Double Vision / Binocular Diplopia after receiving the first dose of the Pfizer Vaccine
June 9 Got a pedicure ( my feet were submerged in water ) 30 mins after leaving felt a pulsating in my back between t8-t12 area wrapping around to front Got worse as time progressed Later that evening spoke with a neighbor who had just had her gall bladder removed Symptoms sounded similar Researched and ruled out gall bladder stuff Looked into vaccine side effects Became aware that some vax are not recommended for people allergic to dairy or family history of autoimmune diseases I have at least 3 known immediate family members with serious autoimmune diseases Mother father paternal grandmother Rhwumatoid arthritis lupus multiple sclerosis I upped my water intake, rested and the pain gradually subsided within a few hours June 14 Took a bath Epsom salt Within 12 hours that same pain t8-t12 came back 10 times worse Upped water again Pain kept getting worse Took ibuprofen Pain got worse To the point where I could not get comfortable and was breaking into a cold sweat After 3 or 4 hours of this I smoked some marijuana, which I had not done since 1-25-2020, Pain went away within 15 mins  Seems like every time I submerge myself in water, this pain happens. I'm now afraid to take baths. Makes me wonder what's happening to our children. I had a severe disdain for taking baths as a child, so much so that I refused. ( I was bullied for being stinky) Wonder why.