chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed red rash (small red area) and low grade fever after vaccination on 1/30/03. Developed symptoms 2/4/03. Red rash over upper trunk front and back.
He has had limited use of right arm and can barely lift it over his head; Extreme weakness on right arm; This is a spontaneous report from a contactable consumer. A 65-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number and expiry date were not reported), via an unspecified route of administration on 12Feb2018 13:30 at a single dose for Vaccination/pneumonia inoculation. Medical history included osteoarthritis from 1993 and ongoing, and Digestive upsets (constipation uses Colace and senna for life). Concomitant medication included docusate sodium (COLACE), and sennoside a+b; both for constipation, to ensure proper passage of intestinal waste. The patient was also taking some pain killers and Benzodiazepines.The patient received the product pneumococcal 13-val conj vac (dipht crm197 protein) for pneumonia inoculation along with vaccines for shingles and 3 others on the same day and the patient had extreme weakness on right arm since then. The patient added that ever since the inoculation, he had limited use of right arm and can barely lift it over his head. The outcome of the event 'extreme weakness on right arm' was not recovered while 'limited use of right arm' was unknown.
immed p/vax pt had anaphylactic rxn requiring hosp visit, Epi & solumedrol;pt had flushing to top of head, then disorientation & unresponsiveness;w/in 3-4 minutes pt experienced swelling, SOB, & blanching of skin; Epi given & to hosp
Patient received first dose of Pfizer COVID vaccine and after 20 minutes complained of tongue as well as roof of mouth itching. Nurse administered oral diphenhydramine 50 mg x 1 dose
Information has been received from a nurse concerning a 49 year old female patient with diabetes, obesity, rectal cancer, currently undergoing chemo and radiation therapy who on an unspecified date was vaccinated with a 0.5ml dose of PNEUMOVAX 23 intravenously via a port line. The vaccine was mixed with 2.2ml of sterile H2O prior to administration. The patient did not report any side effects following the IV administration of the vaccine. It was unspecified if the patient sought medical attention. Follow-up information received from the registered nurse. On 08-FEB-2011, another nurse accidentally grabbed the PNEUMOVAX 23 (lot number 667418/0978Z) instead of another medication that the patient was to receive. When the reporter discovered what had happened one hour later, she withdrew 2ml of fluid from the port so it was unknown how much of the PNUEMOVAX 23 the patient actually received. The patient's relevant concomitant medication included fluorouracil. It was unknown if the patient had any laboratory testing performed. As of the time of this report, the patient was feeling okay. Additional has been requested. This is a consolidation of two reports concerning the same patient.
Pt presented with maculopapular erythema on chest and left upper arm.  Pt was treated at Urgent Care with 4mg Dexamethasone IM and observed for 10 minutes before leaving.  No improvement seen during pt's time here at Urgent Care.
dead in bed; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (001774).  A 14 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), administration date: Jun2021, for COVID-19 immunization . The following information was reported: DEATH (death) with onset 12Oct2021, outcome "fatal", described as "dead in bed". The patient date of death was 12Oct2021. The reported cause of death was "dead in bed". It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: dead in bed
PATIENT REFERS THAT LATE AT NIGHT AFTER A BLACKOUT THE PATIENT EXPERIENCED RASH AND ITCH IN BODY. NEXT DAY EXPERIENCED FACE ITCH.
Pt received immunizations yesterday, Prevnar and Dtap, he had fever at touch yesterday and Mom realized this afternoon that his left arm from shoulder to elbow was red, hot and swollen (10 1/2 x 11cm), no fever today. Pt is not on distress, good ROM.
hot, hard red area around the inject site w/inc pain & soreness that went into the ax area; sl temp 99.4 generalized aching & not feeling good;
hosp x 1wk, 2mo in rehab facility;paralysis-waist down
CHILLS; HEADACHE; FATIGUE; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced chills, headache, fatigue, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, chills, fatigue and fever was not reported. This report was non-serious.
Moderna COVID-19 Vaccine EUA Headache, chills, body aches, fever, nausea
This case was reported by a consumer and described the occurrence of cold in a elderly patient who received Influenza vaccine. Co-suspect products included salbutamol sulphate unknown for chronic obstructive pulmonary disease. Concurrent medical conditions included chronic obstructive pulmonary disease. In November 2014, the patient received Influenza vaccine. On an unknown date, the patient started salbutamol sulphate at an unknown dose and frequency. In November 2014, less than a day after receiving Influenza vaccine and an unknown time after starting salbutamol sulphate, the patient experienced cold. The action taken with salbutamol sulphate was unknown. On an unknown date, the outcome of the cold was not recovered/not resolved. It was unknown if the reporter considered the cold to be related to Influenza vaccine. The reporter considered the cold to be unrelated to salbutamol sulphate. Additional information: the subject was sick, like a cold for the first 23 hrs. This case has been linked with case A1008396A, same patient. Please refer to case A1008396A for tolerance to salbutamol sulphate.
This case was reported by a healthcare professional and described the occurrence of lethargy in a 5-month-old female subject who was vaccinated with KINRIX (GlaxoSmithKline), HIB, PREVENAR and ROTARIX. The subject had no relevant medical history and the previous vaccination went uncomplicated. On 6 May 2014, the subject received unspecified dose of KINRIX (.5 ml, unknown route and injection site; lot number not provided) which led to an inappropriate age at vaccine administration as KINRIX was recommended for children aged 4-6 years. On the same day the following vaccines were also administered: unspecified dose of HIB vaccine (unknown route, injection site and batch number), unspecified dose of PREVENAR (unknown route, injection site and batch number) and unspecified dose of ROTARIX (oral; lot number not provided). On 6 May 2014, less than one day after vaccination with Hib vaccine, KINRIX, PREVENAR and ROTARIX, the subject experienced lethargy. In May 2014, the subject visited the physician due to diaper rash. The doctor informed the subject's mother that the indication for KINRIX was for 4-6 years. At the time of reporting the outcome of the lethargy resolved and the outcome of diaper rash was unspecified.
Within 2 hours my wrist & joints in my right hand have become inflamed & very painful.  I have MCTD but I also have carpal tunnel in both arms.  I had a steroid shot in my Right wrist on 2/12/21 from Dr, which is over a month ago.   The only place I that I am having a very significant reaction is in my right wrist & hand ... so I am not sure why I am having an issue but it is significant & happened very quickly as all was fine before I got the shot.
Blood Pressure and Pulse have been spiking and lowering to close to normal Highest recorded was 233/112 220 MAP pulse 96 Normal for me is 130/79 90MAP 55Pulse
A little sore; Stiff; Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A little sore), MUSCULOSKELETAL STIFFNESS (Stiff) and PAIN (Pain) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery and Back surgery. Concurrent medical conditions included Cancer and Diabetes.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (A little sore), MUSCULOSKELETAL STIFFNESS (Stiff) and PAIN (Pain). At the time of the report, PAIN IN EXTREMITY (A little sore), MUSCULOSKELETAL STIFFNESS (Stiff) and PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included unspecified medications.  Treatment information was not provided.
Pharmacist administered Janssen vaccine, pateint left the vaccination room and was waiting by the pharmacy for the patients vaccination card and fainted onto the floor. Pharmacist attended to the patient on the floor, i called 911. 911 showed up and the patient refused any real medical attention since he did not have insurance. Patient left under his own will.
vaccine was frozen then put it in refrigerator about 24 hours/vial is refreeze; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine was frozen then put it in refrigerator about 24 hours/vial is refreeze) in a male patient of an unknown age 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 TEMPERATURE EXCURSION ISSUE (vaccine was frozen then put it in refrigerator about 24 hours/vial is refreeze). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine was frozen then put it in refrigerator about 24 hours/vial is refreeze) had resolved. Not Provided    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. No treatment information was provided.
School nurse called Mother stating child's arm is red, swollen and warm to touch. Mom picked him up from school and brought to health department where injection was given. This nurse assessed area. Arm was swollen, red and warm to touch. Mom has not given child any medications today. Child states he did sleep on it but started hurting first thing the morning. AROM to right arm. Cap refill less than 3 sec. Child could squeeze my hand. Rated pain a 4/10. Instructed Mom about slight adverse reaction, apply ice a couple times a day for at least 30 minutes. Instructed Mom to alt between TYLENOL and ibuprofen. Dosage handout given to Mom. Instructed Mom, next year when he gets his flu shot, premedicate with antihistamine and do TYLENOL and ibuprofen alt 24 hours after injection. Mom verbalized understanding and has no further questions. Other children in the home did not have any reactions to their flu injection. Child denies any s/s anaphylaxis and if he does to tell Mom right away and go to nearest ER. Later that evening this nurse called to check on patient, Mom stated the child is doing very well.
Day after vaccine : mild shortness of breath, sensation of swelling in my throat/neck area. Took Benadryl 50mg before bedtime.  2 days after vaccine: woke up with voice changes, coughing/choking with speaking. Used epipen once, felt full relief for about 1-2 hours. Trouble speaking again. Then went to ER, had epipen again twice, over two hours, Benadryl 50IV and Pepcid and steroids. Sitting in the ER now debating admission. Likely being admitted., home epipen are too expensive to treat q2h by myself.
was never so sick; Initial information was received on 25-Nov-2020 regarding an unsolicited valid non-serious case received from the patient.  This case involved a male patient of unknown age who was never so sick (malaise) in his life, after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.   The patient was ok till sitting in the hospital for vaccination.   On an unknown date (some years ago), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient was sick (malaise), (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, it was 10 weeks before had strength and felt like himself again and was debating to get this vaccine in 2020.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  There will be no information available on the batch number for this case.
About 2 days after my second dose of the vaccine I experienced painful/very uncomfortable swollen lymph nodes in the armpit area. This was especially on the left side, beside and below the armpit too, and extended to the breast area. It also occurred on the right side in the same areas, but not as severe. This lasted for about 1.5 weeks. It was uncomfortable to have arms at my side/move at all times. Soreness was present even when not moving or with arms up.
Information has been received from a physician concerning an 11 year old female who was vaccinated with Varivax (Lot # 622749/0544E). Subsequently the patient experienced full blown varicella rash (more than 50 lesions). It was reported that the patient was not seen by the physician. At the time of the report, the patient was recovering. The physician reported that another patient had developed full blown varicella rash (more than 50 lesions) after being vaccinated with Varivax (WAES# 0606USA01476).
There has been no adverse event, however I was encouraged by my Department of Health to report an administration error. I had special ordered Daptacel for my daughter for her DTaP series. It's on her file to use this manufacturer vs the Infanrix. Before administration, I asked the nurse if it was the Daptacel and she said "yes" and then administered the vaccine. After I got home and checked the paperwork, I saw that the wrong manufacturer was used, even though it is specified in her file that my daughter is only to receive Daptacel. This is our preference due to different ingredients, however if this was given incorrectly to another child with an allergy or if she had administered a completely wrong vaccine -- it could have been lethal or possibly caused an adverse reaction. So far we haven't seen any symptoms, but will report if we do.
the patient describes large red swelling after the vaccination, which then resolved and left a lump under the skin. On examination, the lump is visible under the skin, and there is a white patch over the lump and red discoloration of the skin.  Similar in appearance to morphea.
Information has been received from an author in a published literature article. The objective was to determine trends in vaccine-type HPV in young women during the 8 years after vaccine introduction, to assess changes in HPV prevalence and characterize herd protection in a community. The authors recruited 3 samples of sexually experienced, 13 to 26 years-old adolescent girls and young women for surveillance studies in 2006-2007 (n - 371), 2009-2010 (n -409) and 2013-2014 (n -400)(thereafter women: N = 1180 from 2006-2014): before widespread vaccine introduction (wave 1) and 3 (wave 2) and 7 (wave 3) years after vaccine introduction. Adolescent and young adult women who were sexually experienced, defined as having had sexual contact (genital-oral or genital-genital with a male or female partner), were eligible to participate using a sequential sampling strategy; those who had participated in the previous surveillance studies were not eligible. Authors determined the prevalence of vaccine-type quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (Manufacturer unknown) among all, vaccinated, and unvaccinated women at waves 1, 2, and 3 adjusted for differences in participant characteristics, then examined whether changes in Human Papillomavirus (HPV) prevalence were significant using inverse propensity score-weighted logistic regression. Among vaccinated participants, vaccine-type HPV prevalence decreased significantly from wave 1 to wave 2 and from wave 1 to wave 3. The same decreases were also significant among unvaccinated participants. The only significant change in any HPV from wave 1 to wave 3 was an increase in any HPV among unvaccinated women. In conclusion, during the first 8 years after HPV vaccine introduction, the prevalence of vaccine-type HPV decreased by >90% in vaccinated young women, demonstrating high effectiveness in a community setting even in sexually experienced young women who may have already been exposed to HPV. This case refers to 26 female patients in wave 2 and 11 female patients of unknown age in wave 3 who participated in the study. On unknown dates, the patients were vaccinated with quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (Manufacturer unknown) (strength, dose, frequency and route of administration were not reported). On unknown dates, the patients were positive for Vaccine-Type HPV. The outcome of the event was unknown. The author considered "positive for Vaccine-Type HPV" to be related to Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recomb. Vaccine (Manufacturer unknown). Additional information has been requested.
I went to administer a flu shot and the glass ring that holds the plunger broke and cut my thumb; I went to administer a flu shot and the glass ring that holds the plunger broke and cut my thumb; This spontaneous case from  was received on 20-Oct-2020 from pharmacist via manufacturing quality assurance (product technical complaint (PTC) reference number: 1068610) and concerned a female nurse of unknown age.   The patient's medical history and concomitant medications were not reported.     On an unknown date, the nurse went to administer Afluria Quadrivalent flu shot (influenza vaccine, dose, route of administration, anatomical location: not reported) to the patient and the glass ring that held the plunger broke (explicitly coded as 'Syringe issue') and cut her thumb. The nurse continued to give the full shot to the patient as the needle was already in his arm. The device assocated with Afluria Quadrivalent was luer lok. The batch number reported was P100257535.   The full dose was administered to the patient. There was no leakage and the vaccine were stored in the refrigerator, as reported.   The outcome of event 'laceration of thumb' was not reported.  The reporter did not provide causality assessment to Afluria Quadrivalent. The reporter assessed the events as related to device luer lok.   Quality assurance investigation (QAI) of Afluria Quadrivalent vaccine, batch number reported as P100257535, (PTC number: 1067455) determined the most probable root cause of broken finger flange on 1 syringe in Afluria_P100257535 in the 2020/2021 campaign was due to packaging equipment at the fill/finish facility. Shipping of the product was also a possible root cause for the event, as it could not be completely ruled out. Since the packaging line was the most likely root cause, the root cause had been assigned as 'Equipment Malfunction' and the complaint was justified.  Additional information received on 04-Dec-2020 from manufacturing quality assurance department: QAI provided. Reporter's information added. Narrative was amended accordingly.  Company comment: Skin laceration and syringe issue were associated with the use of Afluria Quadrivalent. Causality is assessed as unrelated for skin laceration since the injury was a result of broken glass of syringe. Syringe issue is also assessed as unrelated to Afluria Quadrivalent, per company's conventions. 'Laceration of thumb' and 'syringe broken' are assessed as related to device luer lok.; Sender's Comments: Skin laceration and syringe issue were associated with the use of Afluria Quadrivalent. Causality is assessed as unrelated for skin laceration since the injury was a result of broken glass of syringe. Syringe issue is also assessed as unrelated to Afluria Quadrivalent, per company's conventions. 'Laceration of thumb' and 'syringe broken' are assessed as related to device luer lok.
9x8cm area of erythema and warm over vaccination site - localized reaction, starting hours after vaccine administration and growing larger over 48hours. Pt also with one episode of vomiting 1 day after vaccination, likely unrelated (daughter also vomited, was around sick contact).
fluid overload; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (Fever) and FLUID OVERLOAD (fluid overload) in a  patient of an unknown age and 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 PYREXIA (Fever) and FLUID OVERLOAD (fluid overload). At the time of the report, PYREXIA (Fever) and FLUID OVERLOAD (fluid overload) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was unknown.
After receiving the booster vaccine, patient felt dizzy and then proceeded to vomit after feeling nausea and taking a few sips of water. Patient remained seated for 20 minutes of so. Patient said she has had this issue with blood draws but not vaccines. She only ate a granola bar this morning which she thought might have contributed to it. Left for home once she felt better.
p/vax pt devel myalgia & arthralgias;pt to clinic;pt devel angioedema & rash;given solumedrol  IM & pred PO & DPH;swelling about the mouth became sever & rash worsened;seen in ER again dx erythema mult & angioedema;
3/14/09- Experienced diarrhea, vomiting and fever (102.0) for 24 hrs. Had same reaction to Hep B # 1 of 3 on 11/17/2008.
H1N1 given approximately 10:00am 11/18/09. Patient c/o eye fatigue & h/a 1 hour after vaccine. Finished work took acetaminophen 250 mg x 1. Woke up with h/a and stiff neck.
w/in 8hr of vax pt devel inj site swelling which extended to the ankle;leg was painful;the swelling & pain resolved w/in 24hr;
PATIENT STATED RASH STARTED ON LEG A COUPLE DAYS AFTER THE VACCINE THEN SPREAD TO  UPPER LEFT CHEST.  STATED IT WAS ITCHY AND HAS BEEN USING HYDROCORTISONE. PATIENT STATES BEARABLE AND MILD BUT JUST CONCERNED.  I TOLD HIM TO CHECK IN WITH HIS PHYSICIAN TO RULE OUT ANYTHING ELSE AND TAKE AN ANTIHISTAMINE IN THE MEANTIME.
On April 5, I noticed a persistent rumbling sound in my right ear. The sound sometimes, transitions to a high pitched hissing/ringing noise. In May, I went to the Doctor's office and was told I had Tinnitus.