chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was considered medically important for the event of pyrexia. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 5 month 3-week-old female patient who experienced redness at the injection site measured at 2x3 cm and fever of 103. At 23 months of age, the patient received the first dose in May-2010. The patient also received a dose of ROTARIX (GlaxoSmithKline) in May-2010. After receiving her vaccinations on an unspecified date in May-2010, the patient experienced fever of 103 and redness at the injection site measured at 2x3 cm. The patient was taken to the office the next day; treatment was not specified. The reaction is being monitored. The outcome of the events is unknown. The event of pyrexia was considered medically important. The reporter noted that PREVNAR 7 was being saved to be given on next visit instead of PREVNAR 13. No additional information was available at the time of this report.
This spontaneous report as received from a certified medical assistant refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. In August 2016, reported as dates starting on or after 04-AUG-2016, the patients were vaccinated with improperly stored doses of (wistar ra 27-3) M-M-R II lot # L028273, expiry date 28-JUL-2017 and lot # M006544, expiry date 03-FEB-2018 (strength, dose, route and site of administration were not reported). No adverse effect was reported. Administered doses of vaccines experienced the temperature excursion of 35 degrees Fahrenheit for 6 hours and 25 minutes and 47 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous temperature excursions reported. This is one of several cases received from the same reporter. Additional information has been requested.
Pt says arm is still sore and he's having difficulty moving it. Checked pt's arm no bruising no visual problem at am.
Approximately 1/2 hour to 40 minutes post dosage, onset of odd mouth feeling accompanied by drymouth, excessive salivation, and slight numbness in lips.  Persistent at this writing, approximately 4.5 hours later. No escalation of symptoms, bit persistent.
Narrative: Hospitalization, COVID positive and fully vaccinated upon admission, admitted for weakness that occurred for 3 days
p/vax pt devel fever of 102.5 & loose stools w/inc mucus content;pt hosp from 7/10/99 through 7/13/99 because of fever;7/16/99 stools still contained mucus;
Pt reports on April 15th he began feeling fatigue, fever, aches, lip swelling, and soft palate swelling that lasted two days.  Pt said he could not sleep laying down because his soft palate blocked his breathing. Pt reports taking an antihistamine and feeling better after 4 days. Pt showed photos of lip swelling, and he reported it to his health care provider.  His health care provider sent an email that recommended not receiving the second dose of Moderna. However,  pt was automatically scheduled from his first visit to get second dose, and pt showed up to site to discuss it and showed this vaccinator the email and photos and described this course. This vaccinator did not administer second dose of vaccine and recommended discussing alternatives with MD.
Fainted, nausea and sleepy immediately following injection.  Golf ball size lump at injection site.
period is now going on over 7 days; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (period is now going on over 7 days) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     The patient's past medical history included Menstrual cramps.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (period is now going on over 7 days). At the time of the report, HEAVY MENSTRUAL BLEEDING (period is now going on over 7 days) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Normally they are 3 days long, and the longest one ever that she can remember lasted 5 days.  She also said that she had cramps bad when she was young.  The concomitant medications information was not reported. Treatment information was not provided.
Pneumococcal 0.1ml given IM for PPD. Redness 2.5"x1.5". No fever.
Patient presented to Occupational Health services with hematoma in left arm, arm pain, tingling sensation in arm, and inability to raise arm after more than one week of symptoms.
pt recv vax & 2hr later had whelps all over & itching;this did get worse but no other sx;by 3rd day of this saw MD & put on steroids & DPH;took over a wk to go away;MD was not sure this was r/t vax;
PATIENT WOKE UP THE NEXT DAY WITH A SORE ARM, A FEVER OF 102, HEADACHE, AND A STIFF ARM. ON 11/3/16 SHE WOKE UP WITH A RASH AT THE INJECTION SITE AND HEADACHE, BUT NO FEVER. PATIENT STATED IBUPROFEN OR ACETAMINOPHEN DID NOT HELP THE PAIN OR SWELLING.
ACHES; SLEEPLESS; CHILLS; JOINT PAINS; FEVER; NAUSEA; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced aches, sleepless, chills, joint pains, fever, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, aches, joint pains, sleepless, fever and nausea was not reported. This report was non-serious. This case, from the same reporter is linked to 20210451296.
Covid test type post vaccination=Nasal Swab/covid test result=Positive; Covid test type post vaccination=Nasal Swab/covid test result=Positive; my breasts started to be sore; I got my period - a bit heavier and longer then it had been as it was waning with menopause; I got my period - a bit heavier and longer then it had been as it was waning with menopause; I had been in menopause for about 14 months. About 2 weeks after the first dose/ I got my period - a bit heavier and longer then it had been as it was waning with menopause; This is a spontaneous report from a contactable consumer (patient).   A 58-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;Lot Number: EW0185),via an unspecified route of administration in Left arm on 20May2021 (at 58 years) as single dose for covid-19 immunisation. The patient medical history included menopause from 2020. No known allergy. Concomitant medications included levothyroxine taken for an unspecified indication, start and stop date were not reported. No other vaccines given in four weeks. Patient was in menopause for about 14 months. About 2 weeks after the first dose (on 03Jun2021), her breasts started to be sore and a few days later (Jun2021), she got her period,  a bit heavier and longer then it had been as it was waning with menopause.No treatment given and patient recovered on an unknown date in 2021.Later, on 07Jun2021, the patient had nasal swab that resulted positive (Drug ineffective, COVID-19) with outcome unknown.
pt had few pox marks;trunk & face passed to other kids @ sitters;no fever, itching;
Edema, redness, tenderness.  rec: Benadryl, Bactrim empiric treatment.
Caller is an 80 YOF that received the Janssen Vaccine.  Just today she noted that the site was bruised.  she is a retired RN and had them do the Z track method to admin medication.  she does not report pain to site but does say the bruise is noticeable.  She has also noted some memory lapses where she forgets something she just read and this is not typical for her.    adv to continue to monitor site.  may apply warm compresses to site.  if pain, take OTC analgesics.  adv tof/u w/PCP if s/s persist/worsen.
10 minutes after vaccine was given she had trouble breathing, wheezing, coughing, and numbness in the face and neck.
Information has been received from a consumer concerning her 17 year old old daughter who in January 2007, was vaccinated IM with a 0.5 ml first dose of GARDASIL. In March, 2007 the patient received IM a 0.5 ml second dose of GARDASIL. There was no concomitant medication. The mother reported that the patient had swelling on her arm at the injection site, redness, pain, muscle pain over body, and chills lasting for 3 days a few hours after her second dose in March 2007. Patient was not able to attend school. The first dose, which had same symptoms but to a lesser degree, was in January 2007 and was not sure how long the lasted. Medical attention was not sought. On an unspecified date the patient recovered. Additional information has been requested.  07/08/2008 This is in follow-up to report(s) previously submitted on 5/14/2008. Follow up information from the physician regarding an 18 year old female patient with no previous medical history or no known drug allergies or birth defects, who on 28-Nov-2006 (previously reported by mother as January 2007) was vaccinated IM with the first dose of GARDASIL (lot# not reported) and on 30-Jan-2007 (previously reported as in March 2007) the patient was vaccinated IM with the second dose of GARDASIL (lot# not reported). There was no concomitant medication. On 30-Jan-2007 the patient experienced pain-elbow to middle of back (7 of 10). Then decreased to 3 of 10. After 3rd day, then ached for 2 weeks. Some swelling, fatigued, stiffness all over especially arm. The patient complained of not being able to withstand any pressure on arm. Difficulty sleeping because of pain. Cold (Ice), heat and ibuprofen were all tried but no relief. The patient had difficulty with school work which was very unusual. Patient was unable to participate in high school varsity athletics for a week and missed some school classes. Very painful and caused severe fatigue. Reaction was severe that the physician decided to not go for the third shot. It was also reported the patient had no memory of events of first 3-4 days after receiving shot. On 12-Feb-2007 the patient had recovered. Additional information has been requested.
The patient is a 43-year-old male with type 2 diabetes mellitus on Metformin who was well until January 15th when he received a booster dose of the Pfizer COVID-19 vaccine.  Prior administration of 2 doses of the Pfizer vaccine in May 2021 were uneventful.  January 15-18th he was febrile and had body aches. He also experienced an episode on January 16th where he lost his balance and fell in the restroom, and remained down for over 30min. From January 18th to 30th, he continued to feel unwell, with persistent body aches, fevers and extreme fatigue. On January 30th, he developed bilateral ocular redness, mouth and tongue lesions and scrotal lesions. On February 3rd and 4th he experienced high fevers. On February 4th he also had increased lip swelling/numbness, a diffuse red rash over his chest, abdomen and back, and blisters on his hands, feet, and scrotum. He presented to urgent care where he was prescribed valacyclovir and lidocaine solution. On February 5th, his fever and blisters got worse and he went to the emergency room. He was admitted to the hospital the evening of February 5th and diagnosed with probable erythema multiforme major with progression to an SJS/TEN-like picture. He was treated empirically with IV acyclovir, Solu-Medrol (now transition to prednisone), and also received 2 doses of etanercept.  He was transferred to another hospital on 2/16 to the burn unit for additional specialized care. At this point, he had a whole-body desquamating rash. He did not have significant fevers during his hospitalization until 2/16 when he developed fever to 39.1 shortly after his arrival to the hospital.  Blood cultures were collected and have since grown methicillin-resistant Staph aureus in 4/4 bottles.  He was initiated on IV Vancomycin for an anticipated course of 4 weeks.
Pt recvd 3 doses of Engerix-B & 6 months p/3rd dose titer test result was neg, had not responded; will be given booster;
Muscle pains in legs like unto a lactic build up; Nose burning when inhaling, especially in cold air; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration in the left arm  on 06Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history was None. Concomitant medication included escitalopram, meloxicam (MOBIC), acetylsalicylic acid (ASPIRIN (E.C.) and calcium carbonate, colecalciferol (CALCIUM D3). The patient was not pregnant. She had no other vaccines in four weeks prior covid vaccine. The patient had no covid prior vaccination. She had not tested for covid post vaccination. The patient had no known allergies. The patient experienced nose burning when inhaling, especially in cold air. She had muscle pains in legs like unto a lactic build up. These were still happening after 18 days from injection which are worse at night. The events started on 06Jan2021 at 10: 45 AM with outcome of not recovered. No treatment received for the events.  Information about Batch/Lot number has been requested.
Patient became diaphrectic, non-responsive.  Patient was lowered to the ground and vital signs were taken.  Patient found to be hypertensive, legs were elevated and 911 was called.  Patient came to, vital signs were rechecked and within normal range.  Medics arrived and patient declined to leave with ambulance
Pt developed a red, hard knot that became more red and larger in size at injection site (right leg, middle top side). No other symptoms noted. Took child to MD and was determined to be a hematoma and may take 3 months to resolve. 3/10/00, talked with father of child and stated the area is looking better today.
pt recvd vax & 4hrs later exp aches in both shoulder, arms, legs, low grade fever, diarrhea;no treatment given pt feeling better by the next day 5APR95 & has gone back to work
Fatigue; Felling Sick; Slight Fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), ILLNESS (Felling Sick) and PYREXIA (Slight Fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020 and COVID-19 in December 2020.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced FATIGUE (Fatigue), ILLNESS (Felling Sick) and PYREXIA (Slight Fever). At the time of the report, FATIGUE (Fatigue), ILLNESS (Felling Sick) and PYREXIA (Slight Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.   The Patient refused to give contact details. un-coperative, thinks it was a scam call and repeatedly disconnected.   This case was linked to MOD-2021-070386, MOD21-071030, MOD21-071138 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: TCR-Follow up received on 26-May-2021 contains no new information-Patient refused to give details.; Sender's Comments:  MOD-2021-070386:Case for second dose MOD21-071030:cross linked case MOD21-071138:cross linked case
Vaccine had a low temp excursion.  Revaccinated per Sanofi-Pasteur recommendation.
Pain in right arm; Headache; Severe diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 08Mar2021 at 13:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Mar2021, the patient experienced pain in right arm, headache and severe diarrhea. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in right arm, headache and severe diarrhea were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
feel I may have some longer lasting effects in my bicep muscle and shoulder joint; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 15Jan2021 (Lot number: EL1283) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "feel I may have some longer lasting effects in my bicep muscle and shoulder joint".  No follow-up attempts are possible. No further information is expected.
I started with aching; Chills; Sleeping all the time; Sore throat; I cannot hardly talk; I have never been this miserable in my whole life; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Vaccination. The following information was reported: CHILLS (non-serious) with onset Oct2022, outcome "unknown"; SPEECH DISORDER (non-serious) with onset Oct2022, outcome "unknown", described as "I cannot hardly talk"; FEELING ABNORMAL (non-serious) with onset Oct2022, outcome "unknown", described as "I have never been this miserable in my whole life"; PAIN (non-serious) with onset Oct2022, outcome "unknown", described as "I started with aching"; SOMNOLENCE (non-serious) with onset Oct2022, outcome "unknown", described as "Sleeping all the time"; OROPHARYNGEAL PAIN (non-serious) with onset Oct2022, outcome "unknown", described as "Sore throat".  Additional information: It was reported that patient felt perfectly fine and got this COVID -19 (confirmed as Pfizer COVID-19 vaccine) on Tuesday and Wednesday started with aching, chills and sleeping all the time for 2 days. Patient stated, this was the 3rd day and started, well started yesterday afternoon with the worst, patient thought was getting better and then got the worse sore throat that ever had. When asked if had any questions regarding the concern patient stated, no just wanted to report these symptoms because had the other COVID shots and have not had anything, had all this. Patient thought will never have another one. Patient never had COVID (general statement). When asked to proceed with the question patient stated no cannot, hardly talk. Patient had never been this miserable in whole life.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
very swollen and somewhat painful lymph node in the armpit of the arm being innoculated. Reduced in size after 24 hours, on track to largely disappear in 48 hours.
She was fine for the first 4 hours. Started to hurt at the inj site. Did not take diabetic meds with dinner that night. Around 11pm didn't feel well. was shaking. Took diabetic number, 65.  Normal count 115.  Thinks that the covid inj lowered her numbers. After eating cookies with milk it went up to 112. She felt better. If she had taken her meds, her numbers would have been around 50.
Patient had a severe headache which he called a migraine at 3:00 pm at school.  I gave him 200 mg of generic motrin at 4:00 pm at home.  The headache did not completely go away.  He was somewhat lethargic that evening and stayed on the couch.  The next morning he could not walk.  He had severe pain in his feet.  The pain rose up to his legs and waist by 2:00 in the afternoon.  12/07/09 H&P received for DOS 10/28/09. DX: paraparesis and HA  Pt admitted to ED with c/o vomiting, severe HA, rash, stabbing BL leg pain, low grade fever, unable to eat/drink. Fever and vomiting resolved. Neuro exam: positive for weakness and HA, negative for sz, syncope and speech difficulty. Pt transferred to Neurology and the tests were wnl; brain MRI: wnl.
Information has been received from a physician concerning a male patient who on unspecified date was vaccinated with the first dose of ROTATEQ. It was reported that the patient experienced diarrhea and blood in his stools after receiving the first dose of ROTATEQ. The patient sought unspecified medical attention. Upon internal review, hematochezia was considered to be an other important medical event. Additional information has been requested.
This spontaneous report has been received from a nurse regarding multiple unspecified patients of unknown age and gender. The patients concurrent condition and medical history were not reported. On unknown date in October 2015 ranging from 20-OCT-2015 to 28-OCT-2015, the patients were vaccinated with improperly stored PEDVAXHIB (lot # L014429, Expiry date: 15-MAR-2018) (strength, dose and frequency not reported). No adverse events were reported. This case is one of 2 reports from the same reporter. Additional information has been requested.
pt recv vax 1OCT97 & 9OCT97 pt devel full blown chickenpox w/greater than 100 lesions which involved face, chest, back & extremities;also had temp 101.9;
p/vax pt exp hard time walking; joint pains; chronic fatigue; night sweats; diarrhea continuously since 4/99; aches all over, flu like sx,sick leavex20 days, neg for Crohn's disease; for liver bx 9/22/99 d/t inc liver enzymes
This spontaneous report as received from an healthcare student refers to a 1 year old patient of unspecified gender. On 05-NOV-2013 the patient was vaccinated with PROQUAD (route, dose and lot number unknown) and with VARIVAX (route, dose and lot number unknown). No other suspect therapy or concomitant medication was reported. On 05-NOV-2013 an unspecified nurse administered PROQUAD and VARIVAX in error on 05-NOV-2013. No adverse event. Additional information has been requested.
Glucose level dropped dramatically in middle of night.   Has not dropped below 80 in over a decade and it was 62 and dropping according to my Dexcom.   Had eaten normally and taken meds on schedule.    Only thing different was vaccine.
This spontaneous report as received from a pharmacist refers to a 70 year old patient of unknown gender. The reporter stated that the patient was administered a dose of PNEUMOVAX 23 (dose, strength, lot #, route and site of administration not reported) within the past five years and subsequently was administered another dose of PNEUMOVAX 23 intramuscular (dose, strength, lot # and site of administration not reported) on 08-OCT-2013. No adverse effect reported. Additional information has been requested.