chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt had redness, swelling, pain at injection site and went to the ER the next day.  Has had several more trips to the doctor since then.  Says she has take several different antibiotics and a steroid.  Her mother says she told patient to rub the injection site after the shot because she thought that was what you shoud do after a tetanus shot.  Client says her doctor said the shot was given too low in her arm, and not given deep enough.  As of 8-13-10, she continues to have redness, soreness & pain in arm.  She says the doctor is not sure what is going on with it, and may do an ultrasound on 8-16-10 if it is not better.
Itchy at the site and then a red circle about 3in  This happened one week after shot
Pt presented to clinic the following day w/ 6 cm in width almost circumfrential area around L upper arm w/ associated warmth, TTP consistent w/ very large local rxn vs cellulitis. Pt was afebrile and w/o any difficulties breathing, managing secretions, other rash, vomiting or diarrhea.
On Dec 26, 2021 I started to feel sick. I was so fatigued I could barely get out of bed. On Dec 29, 2021 I went to the urgent care and I was swabbed for COVID and flu. Both were negative. My blood pressure was extremely low so I went to the emergency dept at a local hospital. I was hospitalized until January 1, 2022 with extremely elevated liver enzymes. It was thought that I had autoimmune hepatitis but bloodwork was taking a long time to come back. I was discharged with instructions to see a hepatic specialist. It took 3 weeks for bloodwork to come back. I then got a liver biopsy on January 19, 2022. It was determined I did have autoimmune hepatitis. My liver was very necrotic so I began treatment with a high dose of Prednisone.
Absolute exhaustion, TERRIBLE body aches literally everywhere, and chills but no fever, some nausea that comes and goes
Pfizer-BioNTech COVID-19 Vaccine EUA Racing heart. She described a pain and fluttering feeling in her chest and feeling weak and faint. Her skin was clamy feeling and no fever. I  could feel her little heart pounding. I  had her lay back down again and did some slow breathing with her and gave her children's ibuprofen The episode lasted about an hour then her heart slowed down and she fell asleep. She was sluggish and fatigued the next day and felt fine by day 4. I did not take her to the doctor because it eventually stopped. I  don't know what it was or if it caused any damage. She seems ok.
SWEATING; BODY HURT ALL OVER; NO APPETITE; CHILLS; BAD NAUSEA; This spontaneous report received from a patient concerned a 20 year old female. 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: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol. On 08-APR-2021, the subject experienced sweating. On 08-APR-2021, the subject experienced body hurt all over. On 08-APR-2021, the subject experienced no appetite. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced bad nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating on 09-APR-2021, body hurt all over, and no appetite on 11-APR-2021, chills on 08-APR-2021, and bad nausea on 12-APR-2021. This report was non-serious.
substantial bruising on my side ribcage and side of my breast; First swelling in my armpit; This spontaneous case was reported by a patient and describes the occurrence of CONTUSION (substantial bruising on my side ribcage and side of my breast) and LYMPHADENOPATHY (First swelling in my armpit) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient had no medical conditions.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONTUSION (substantial bruising on my side ribcage and side of my breast) and LYMPHADENOPATHY (First swelling in my armpit). At the time of the report, CONTUSION (substantial bruising on my side ribcage and side of my breast) and LYMPHADENOPATHY (First swelling in my armpit) had resolved.            No concomitant medications were reported. Patient had received all moderna vaccine and boosters dose. No treatment medications were reported.
Case number PHEH2014US003776, is an initial spontaneous report from a pharmacist received on 21 FEB 2014. This report refers to a 16-year-old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with one dose of FLUCELVAX 2013/2014 (batch number: unknown) at 0.5 ml intramuscularly on 30 NOV 2013. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Dose was give when in syringe >12 hours. Aseptic Technique was used
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported, that on unspecified dates in July 2014 and August 2014, the unspecified patients were vaccinated with (Oka/Merck) VARIVAX (subcutaneous injection, 0.5 ml once, subcutaneous, strength, lot #, expiration date and anatomical location not reported), that was improperly stored at a maximum of 7.5F for up to 11 hours. No adverse effects reported. Thi sis one of 2 reports from the same source. Additional information has been requested.
red bumps around injection site with rash that spread to bilateral arms and back raised red, scabbed areas. after 2nd vaccine, similar reaction on chest, scalp and legs with initial rash that has worsened
Client experienced redness (8" x 6") tenderness, warmth, swelling on upper (L) arm at the site on her arm where she received her PNEUMOVAX about 1d after receiving the vaccination. 2 days after she had swollen tender lymph nodes in neck, aches, fever (102 degrees)/chills, extreme fatigue. She still has silver dollar size hard tender bump at inj site - most is clearing by today 5/19/14.
pt went to the car and came back after 30 minutes and said she was feeling clamy and thirsty.,  we gave her some water. she said she was just getting hot. after about 15 more minutes she said the water was a little hard to swallow so we gave her benadryl 25mg.   we watched and waited for an additional   20 minutes and she  she was feeling better but then she said her eyes were getting blurry so we called 911. i was in the middle of taking bp when  ems got there and took it and was 80/40. she then said her bp was 80/40 at dr's office that morning also ( she told me she had high blood pressure) . the ems thought she was dehydrated but she was having clogged ears so they took her to er by ambulance. she got onto the gurney on her own
The following day after my injection, I had bright RED hives all over my body except for my face and hands.  It was very uncomfortable.  I tried to calm my skin with lotions.  As the days progressed, the color receded and all of my skin started to peel.  It was terrib ly itchy and difficult to wear clothing. It took about a week for it to calm down, and the peeling continued for another week.
patient was seated in waiting area when fainted and fell out of chair  and  hit head - was responsive - ems came and took to hospital to be checked out - Mom reported Doctor said normal reaction to teen receiving shot - mild concussion from hitting head
PATIENT HAD REPORTED THAT DURING HIS 1ST J&J VACCINE HE HAD EXPERIENED NAUSEA AND MAY HAVE FAINTED. PATIENT STATES NO ISSUES OCCURRED WITH OTHER VACCINES SUCH AS THE FLU SHOT. PATIENT BEGAN EXPERIENCING NAUSEA, AND DIZZINESS ABOUT 2 MINUTES AFTER RCEIVING THE VACCINE. PATIENT ALSO STATED HE FELT HIS TEMPERATURE RISING. I GAVE PATIENT WATER AND ICE PACK. NO FEVER WAS EVER RECORDED. PATIENT DID NOT VOMIT BUT STAYED HUNCHED OVER IN CHAIR FOR OVER 10 MINUTES. PATIENT ALSO BEGAN SHAKING AND REPORTED SOME TINGLING IN ARMS. 911 WAS CALLED AND PATIENT WAS GIVEN SOME SALTINE CRACKERS WHICH SEEMED TO HELP GREATLY. ALL TESTS FROM PARAMEDICS CAME BACK NORMAL.
pt noted fine rash on arms while @ school; also felt woozy; mom picked pt up from school & noted rash on body, legs, arms, which is fine; t99.6 po; poss stress induced reoccurrence of parvovirus;
Patient said she felt chills and fever, very severe flu like symptoms. She felt she could barely walk or lift her arms, and wasn't sure if she would "make it through the night." By morning symptoms were starting to subside.
day p/vax pt exp swollen red hands & feet; pt currently being monitored in hosp
Pt stated she had red /hard knot about the size of a 50 cent piece on her arm at the area of the injection.  Advised pt to use ice and/or take loratadine and to watch for any signs of streaking/increased redness/ or fever.  If she experienced any of these symptoms to go to er. Told patient, pharmacy would call back in a few days to check on her
I had a large lump develop just above the injection site.  It was hot to the touch, and there was arm pain.  It's been almost a week since receiving the vaccine and it's not hot, but the lump is still quite sizeable, hard, but doesn't feel hot.  Every so often I have pain, and I cannot put pressure on the upper arm.
This report is received from a consumer (patient's mother), as part of a marketing research program, refers to a female patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date, the subject was vaccinated with a dose of MMR (manufacturer unknown) (lot #, expiration date, dose, route and site of vaccination were not reported). Concomitant medications were not reported. On an unknown date (few days after vaccination), the subject had a reaction and she passed out playing in the car. The reporter's husband ran her limp daughter to a doctor. The patient was fine but the final outcome of the events of passed out and unspecified reaction was not reported. The relatedness between the events and MMR (manufacturer unknown) was not reported. Additional information is not expected as there was no consent for further contact.
Patient fainted and fell to floor. Rapid pulse, did not lose consciousness.  Reported temperature of 99.8, redness and pain. School nurse sent student home from school.
jaundice & hepatitis 7 days p/vax;17APR ALT 163;14APR AKLP 329;AST 85;LP 725;GGt 622;+Bili 5.5;ALKP 329;AST 95 LP 725;
Returned to clinical with complains of nausea and weakness began on hour after administration of vaccine. Feeling better when left clinic.
Got a flu shot on Oct. 11 and had very strong reaction and personal injury. I had a little fever for two days. On Oct. 28, I felt uncomfortable on my left face. Two days later, the situation became worse. I could not close my left eye and mouth. My left side facial nerve and muscle were totally out of control. So I went to Hospital ER to check what was wrong. Doctor diagnosed finally I got Bell's Palsy because of virus infection. However during that time period, I did not have any virus touched or infected except the flu shot virus that was injected into my left arm. My primary doctor confirmed last Friday that it was highly possible that my face paralysis was related to the flu shot. 12/4/07-records received for DOS 10/30/07-DX: Bell's Palsy CN VII neuropathy. C/O left sided facial numbness. History of 3 days with facial paralysis unable to closee left eyelid. Able to wrinkle forehead.  Per 60 day follow up: I want to investigate the side-effect of the vaccine Influenza that the manufacturer did not tell patients or did not realize.
Severe jaw, ear, neck and head pain.  Dry mouth, sore throat, fatigue and sore muscles.  Facial numbness.
Patient developed Bell's Palsy shortly after vaccination.  4/17 was vaccine. Symptoms began 5/1. Seen in ED 5/4.
Red, itchy rash and swelling developed  near the injection site a few days after vaccine. The itching and redness subsided after approximately a week. However, now at four weeks since first dose, the area is still slightly discolored with dry skin.
anterior thigh w/scattered 1mm macules approx 1cm apart extend over area consistent w/area cleasned;no palpable nodule nor fluctuance; 1mm blue area @ inj
she is rickety, and as she starts moving, she is ok, not in pain; legs and arms ache; inflammation rate was a little high; it is hard to sleep; legs and arms ache; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: E10142, Expiration date: not reported), dose 1 via an unspecified route of administration on 20Jan2021 as single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On Jan2021 the patient experienced adverse events reported as "she is rickety, and as she starts moving, she is ok, not in pain, she had legs and arms ache, inflammation rate was a little high, it is hard to sleep." The patient wanted to know if anyone else has the same symptoms, and should she be getting the second dose. The patient underwent lab tests and procedures which included blood test normal, inflammation rate a little high on 26Jan2021.The outcome of events legs and arms ache, Crepitations was not recovered and for inflammation, hard to sleep Was unknown.  Follow-up attempts are completed. No further information is expected.
I have been sick since July 16 at 8:00 pm  I have been unable to work  I felt so ill my husband took me to the Doctor on July 22 . They test me for Covid and flu and both were negative. I have been having chills hot flashes headaches joint aches and very weak
Patient was given 5 vaccines. 1 oral and 2 injections in right leg and 2 in left leg.  Oral Rota was given first, then 2 shots in right leg.  Patient began crying and then holding breath.  Parent blew in face and child began crying.  Continued to administer 2 shots in left leg.  Patient began holding breath again and lost consciousness.  Was unresponsive for 30 seconds to 1 minute.  Nurse practitioner came into room and Dr. Both began blowing in face and patient awoke and was responsive.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 09-JUN-2015, the patient was inadvertently vaccinated with an improperly stored dose of GARDASIL (lot # K006191) expiry date: 02-FEB-2017 (dose and route were not reported). No adverse effects reported or Product Quality Complaints (PQC) involved. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact.
The patient was in office for routine appointment. The patient requested a Pfizer booster vaccine, Doctor placed the order for the nurse to give the Pfizer booster. The nurse went over the pre vaccination check list and patient signed that he met requirements for the booster. After giving the vaccine the nurse was updating his vaccination card and discovered patient had received his 1st vaccine 4/22/21 and 2nd dose 10/1/21. Once the nurse discovered 5 months have not lapsed since last vaccine, she reported it to the ordering provider. The patient has been notified that he has received his booster too early- patient is doing well no symptoms or adverse reactions noted.
Doctor gave 2nd booster shot with family consent and with verifying that patient had already received the booster. Doctor also did not record the vaccine statistics (lot number, etc.). Manufacturer was also different than the previous 3 correct doses.
1st dose administered to a 17 year old patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to a 17 year old patient) in a 17-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to a 17 year old patient). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to a 17 year old patient) had resolved.        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.   Concomitant product use was not provided by the reporter.  Pharmacist reported the patient was almost 18 years of age but not completely 18 years old yet.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-077679 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077679:Crosslinked (MOD21-076257)
Information has been received from a nurse concerning a 19 year old female patient with asthma, depression and allergies to valproate sodium, diazepam, gabapentin and acetaminophen (+) butalbital (+) caffeine who on 18-DEC-2006 was vaccinated with her first dose of HPV rL1 6 11 16 18 VLF vaccine (yeast), 1pt #654540/1161F.  Concomitant therapy included montelukast sodium (MSD), escitalopram oxalate, lansoprazole, and metoprolol succinate.  On 20-DEC-2006 the patient called the office and stated that the injection site was itchy. Medical attention was sought.  The physician's office to follow up with patient, her outcome was unknown. Additional information has been requested.
01/13/2022:  Event occurred after 2nd vaccine.  33-year-old male who presents to the emergency department with a outpatient CT that was positive for appendicitis.  Patient states that he has developed generalized lower abdominal pain yesterday evening. in has been so intense that he has vomited multiple times.  He also states that he woke up with a fever on Monday.  He denies cough, sore throat, congestion.  He states that he was tested for COVID and influenza this morning and he reports that his COVID test was positive.
Chronic fatigue, fibromyalgia, joint pain, tender behind knees, difficulty getting up from sitting position, difficulty climbing stairs, decreased flexibility (bending over to pick up objects), decreased appetite.
pt recvd vax & w/in 48 hrs pt devel soreness @ the inject site;
significant chills; slight dizziness; sore throat; had substantial body aches; fatigue; This is a spontaneous report from a contactable consumer (patient) A 44-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number el3248, Expiration date unknown), via an unspecified route of administration, in arm left on 01-FEB-2021 at 09:15 single dose for Covid-19 immunization. The patient previously took vaccine which included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number el3248, Expiration date unknown) via an unspecified route of administration, in arm left first dose on 12Jan2021 at 06:30 AM for Covid-19 immunization. Prior and Since to vaccination, the patient not diagnosed with COVID. Concomitant medication was not reported. on 02-FEB-2021 03:00 AM patient experienced significant chills, slight dizziness and a sore throat, substantial body aches and fatigue. The patient woke up at 3 am with significant chills, some slight dizziness and a sore throat. The patient was able to go back to sleep, when the patient woke up again in the morning the patient had substantial body aches and fatigue.  I took some motrin and tylenol in the morning. The symptoms subsided by the afternoon. The symptoms subsided by the afternoon. The outcome of event was recovered.
This spontaneous report as received from an other health professional refers to patients of unknown age and gender. Since June 2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 for prophylaxis reconstituted with sterile diluent (STERILE DILUENT). No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA001903: US-009507513-1709USA001915: US-009507513-1709USA001916: US-009507513-1709USA001917: US-009507513-1709USA001919:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 3:45 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 21.32 on 20-Mar-2021.  Concomitant products were not provided.  On 20-Mar-2021, Excursion time was 09 AM, temperature was 34 and 10 AM the temperature was 37, total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021.~ On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM: 43.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Within minutes I felt a sudden fatigue and weakness. I couldn't even load my husbands wheelchair into the car. These symptoms were consistent for about 2 days. Half way through the third day the symptoms just disappeared and I felt fine.