chrisvoncsefalvay/vaers-outcomes huggingface dataset:
joint pain; tiredness; This is a spontaneous report from a Pfizer sponsored program.  A contactable male consumer (patient) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced joint pain and tiredness, non-serious on an unspecified date with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 29-JUN-2015, the patient was vaccinated with improperly stored dose of ROTATEQ oral, lot # K011947, expiration date 07-JUN-2016. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Large Red splotchy rash on arm. Itching. Some pain to touch. Onset approx. 7 days from vaccination.
1.6 ML of vial were administered into left deltoid by MA.  Evaluated by MD, observed x 45 min,  monitored vital signs, gave water, detailed instructions for symptom monitoring and increased hydrating liquids, followed up by phone with patient 2 hours after leaving. Appt made for patient to follow up with provider tomorrow 7-22-2022.
Patient is a 80 y.o. female patient of, MD with a history of    Discharge Diagnoses:   1. COVID pneumonia              - vaccinated and finished antiviral (recommended by econsult to ID)              - finished paxlovid  2. Asthma exacerbation 3. Symptomatic bradycardia       Coumadin due to high CHADS2 score            4.Anemia of chronic disease   5. Hypothyroidism   6. Hx of ileus and gastritis   7. Hx of thoracic aortic aneurysm   8. Deaf status             - Used Martti for ASL and writing    9. Strep pneumo + urine 1. Continue Rocephin (day 5) 10. Abdominal pain  11. Shoulder pain              - xray with moderate AC joint OA  12. Back pain              - osteoporosis with moderate T4 compression fracture; chronic      Patient was admitted through the emergency department with a cough and a chest x-ray concerning with perihilar bronchitis versus a multifocal pneumonia and effusion.  Did appear somewhat similar to her previous chest x-ray in January.  Patient was not requiring any oxygen.  She was found to be COVID-positive.  E consult was placed I discussed with the infectious disease who states patient would qualify for Paxlovid.  Patient is agreeable to taking this.  She should hold her simvastatin as well as risperidone while taking this.  Patient is currently on room air.  She feels comfortable with discharge to home.  Was initiated on Rocephin- completed course.  Due to her significant asthma history and significant wheezing yesterday we will also place on steroids to help with asthmatic flare. Episode of a.fib with RVR and elevated CHADS2 score; cardiology recommended initiation of Coumadin therapy.  Patient will be started on 5 mg of Coumadin daily.  Is to have a recheck of her INR in 2 to 3 days.  Outpatient follow-up with primary care.   While hospitalized patient did develop abdominal pain.  Due to his CT scan was concerning for potential partial small bowel obstruction.  Patient was evaluated by general surgery and had a repeat KUB today that did not show any evidence of obstruction.  Patient was able to have bowel movement today.  Endorses no abdominal pain and feels comfortable being discharged home.  Outpatient follow-up with primary care.
fever 22AUG95; fever, lethargy & sz 23AUG95 @ MD's office-to hosp then transferred to another hosp;LP w/pleocytosis & inc protein; bacterial & viral cx's neg; gaze preference & hemiplegia p/diff to control sz;changes c/w encephalitis on MRI
Had initial ?normal? side effects in the first few days following injection (sore arm, swelling at injection site). Those side effects had fully subsided by around 3 or 4 days after the injection. Then, around 7 days after the injection, the injection site began swelling again and became red. Site of swelling is about the diameter of a baseball currently (now 9 days after injection). It does not hurt and I do not have a fever or other symptoms. I went to an urgent care facility today to have it looked at. The doctor said it is unlikely that it is something like cellulitis and is likely a localized immune response that should get better on its own.
Information has been received from a physician concerning an approximately 13 month old previously healthy female with no medical history who on 7/10/03, at 12 months of age, was vaccinated with a dose of varicella virus vaccine live (lot # 641709/0330M). Concomitant vaccinations on that same day included a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine. The physician reported that in August 2003, the patient presented to his office with numerous neurological problems including head deviation to her side which progressed to ataxia and crossing of her eyes. By the end of 2003, the patient's initial symptoms resolved on their own. In 2004, the patient's symptoms returned and in April 2004 she was admitted to a hospital and placed on a ventilator. At the time of this report, the physician indicated that the patient remained hospitalized, was a paraplegic, was still ventilator dependent and her current status was that of severe neurological devastation. The reporting physician was unsure if the patient's events were vaccine related. The reporting physician also considered the ataxia, crossing eyes, ventilator dependent, paraplegia, and severe neurological devastation to be disabling. Additional information has been requested.
Temperature went down to 94.6 F; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE DECREASED (Temperature went down to 94.6 F) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced BODY TEMPERATURE DECREASED (Temperature went down to 94.6 F). On 18-Jan-2021, BODY TEMPERATURE DECREASED (Temperature went down to 94.6 F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 94.6 (abnormal) temperature went down to 94.6 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.; Sender's Comments: Very limited information regarding this events has been provided at this time. Company assessed the events to be unlikely related to company product.
came back 2 days after vaccination with redness/swelling/heat on the arm approximately 2 inches below injection site about 2-3 inches wide. says it started day after vaccine and had soreness and light fever that was improving, but was concerned about redness/swelling/heat rash on the arm. she said she will keep an eye on it but didn't want to go to the doctor yet. said to keep an eye on it and go to md if any sign of getting worse or sign of trouble breathing. currently not experiencing any trouble breathing or signs of severe allergic reaction.
Severe headaches, loss of balance, and darkening and blurriness of vision in one eye, was prescribed Prednisone by healthcare provider.
January 19th, I started having a severe sore throat. I waited 24 hours before seeking care. I never ran a fever, but within 24 hours started having a severe headache and the worst head congestion I have ever experienced. I was very tired, and stayed in bed for 3 days except to bathe and eat.
Approximately 15 minutes after vaccination, pt began to feel flushed, tachycardic, and mildly dizzy. BP and HR were elevated at 148/70 and 102 respectively. 5 minutes later her symptoms began to resolve, BP 138/82 and  HR 85. After another 5 minutes, pt reported symptoms were fully resolved and monitoring was discontinued.
Swelling; soreness; warm-to-touch; red. Went away for 4 days then came back and started to itch. After taking Motrin, swelling went down but still sore and the red patch has grown.
got covid; got covid; 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 59 year-old male patient received bnt162b2 (BNT162B2), administration date 09Jun2021 (Batch/Lot number: unknown) as dose 2, single and administration date 20May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: Jan2021 (unspecified if ongoing). The patient took concomitant medications. Healthy 59 year old male who does vitamins. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "got covid". Patient never got booster yet but got covid for Christmas. This time was as bad as the first time fever, body pain, head confused but this one also came with a bad case if hives. Patient was allergic to nothing so thinking it's how her body fought this off. Patient was negative as of 05Jan2022 but interested in blood sample for testing. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) negative.  The lot number for bnt162b2 was not provided and will be requested during follow up.
1042: Pt c/o tingling in Lt arm and heavyness in Rt arm. Pt showed S&S of anxiety. BP: 158/84, P: 68, T: 98, Spo2 94% RA. 1055:  Pt reported having high anxiety r/t getting vaccine. 1108: Pt reported feeling better, instructed to call PCP for worsening symptoms, or 911 for emergencies such a SOB. Pt released. RN
Injected H1N1 vaccine Friday Nov 6 @ 2:45. Saturday 12:00 noon after eating lunch went to ride bike (tricycle) + mom found in Grand Mal seizure ~ 2min. later11/12/2009 Ed record for 11/7/2009, patient with c/o's seizure activity, turning cyanotic. Neuro exam was normal.  Tx: IVF, Tylenol. no DC DX noted
The area around injection site (upper right arm) became mildly itchy and a red, warm area appeared (3x4 inches in size) just above injection site.  It is not a surface rash and the itching is from under the surface of the skin. The red area is slightly swollen and feels bruised when pressed. This appeared 8 days after my injection. My arm was very sore after the initial injection and for several days after, but faded days before it began itching. The evening of the injection I also had flu-like achiness that was gone the next day.
First vaccine was and my 2nd was Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First vaccine was and my 2nd was Moderna) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination:  COVID-19 VACCINE (First dose). Past adverse reactions to the above products included No adverse event with  COVID-19 VACCINE.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First vaccine was and my 2nd was Moderna). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First vaccine was  and my 2nd was Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient stated that it had been 6 months since last vaccine.  No concomitant medications were reported  No treatment information was provided
This is a spontaneous report from a contactable consumer who reported for herself. A 69-year-old female patient received PREVNAR 13, via an unspecified route of administration, on 20Nov2015, at 0.5 ml single. The patient's medical history and concomitant medications were not reported. The patient could not lift arm first day (20Nov2015). Patient's arm was very painful on 20Nov2015 night. The patient was hospitalized the same night for 9 days. On 21Nov2015 a small nodule came at the injection site and redness around it (got worse after day 2, nodule and redness 1 week/ day 2-9), small wheal appeared under the nodule (got worse day 2-9). Arm was extremely painful for 2 days. Redness progressively got worse, nodule and wheal continued to get larger and got worse. On day 5 the patient was told to take BENADRYL and use warm compress. Small wheal under the nodule got worse (wheal 2 inches and redness 3 and a half inches gradually receded after 9 days). Her nurse practitioner asked her to take CLARITIN and to put one compress on it. Therapeutic measures were taken as a result of the events and included treatment with TYLENOL compress, BENADRYL on day 5 and local cortisone cream. The events recovered. Follow-up (23Feb2016): New information received from a contactable consumer includes: events details, events added, treatment details, hospitalization.
04/06/2022  I woke up and my right arm was very painful, not the normal hurt after vaccines. It felt like it was on fire.  Within a few hours, the whelp was the size of a peach. My arm was very red and swollen, it was terrible.  This lasted for about three weeks. I was unable to use my arm. The whelp became hard. I continued to put cold compress on it, but this did not help. The glands under my right arm were also swollen.  I have recovered.
Shingles; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 11Mar2021 15:00 (Batch/Lot number was not reported) as single dose at the age of 69 years old, for covid-19 immunisation. Medical history included allergy to penicillin and quinolones, and patient cannot eat cheese and other ages food (not an allergy, a sensitity). The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient takes unspecified concomitant medications. The patient previously took ciprofloxacin and codeine and experienced allergy with these medications. The patient previously received first dose of bnt162b2 on 11Feb2021 at the age of 59 years old for COVID-19 immunization (product: COVID 19, brand: Pfizer, lot number: EI3302, administration time: 01:00 PM, vaccine location: right arm). The patient did not receive any other vaccine four weeks prior to COVID vaccination. The patient experienced shingles on 12Mar2021 19:00. Therapeutic measures were taken as a result of shingles as Veltrex and triamcinolone were given as treatment to the patient. The event resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient was hospitalized due to the event on an unspecified date. The patient has not recovered from the event.   Information on the lot/batch number has been requested.
2 hrs after flu shot hives, no respiratory Sx, no Hx egg allergy; Benadryl.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 25-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported.
Extremely vivid dreams about killing herself; Panic attacks; Extreme pain on injection site; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL DREAMS (Extremely vivid dreams about killing herself) and PANIC ATTACK (Panic attacks) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Prozac).   On 07-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced ABNORMAL DREAMS (Extremely vivid dreams about killing herself) (seriousness criterion life threatening), PANIC ATTACK (Panic attacks) (seriousness criterion life threatening) and VACCINATION SITE PAIN (Extreme pain on injection site). At the time of the report, ABNORMAL DREAMS (Extremely vivid dreams about killing herself), PANIC ATTACK (Panic attacks) and VACCINATION SITE PAIN (Extreme pain on injection site) outcome was unknown.            Concomitant products were not provided. Treatment information was not reported.  Company Comment:  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Information has been received from a consumer concerning a 13 month old male with no known drug allergies who was vaccinated with a dose of COMVAX. Subsequently the patient developed fever and hives all over the body. There was no laboratory or diagnostic tests performed. Unspecified medical attention was sought. At the time of the report the patient had not recovered. Additional information has been requested.
Per Parent approximately 1 hour after injection, pt was dropped off at daycare there she had a episode with tonic-clonic movment. Event was witnessed by security camera and staff, when she fell forward and had tonic-clonic movement of her lower extremities and contractions of her upper extremities. Pt was post ictal  for ~ 20 min.  No bowel or bladder incontinence noted.  Pt was seen at ED
Day 8 Swollen lymph nodes Day 8 and following large arm rash below injection site, warm to the touch
Patient states that shot was administered too high on the arm causing pain and not being able to bend arm after shot was given and thru the evening
About 12 hours following the shot, woke with fever, chills,body aches, stiffness & severe headache. Most symptoms receeded after about 24 hrs. Except headache which turned in to an unusual migraine. by Monday May 10th I was taken to the ER by my cousin. Received 3 or 4 shots for the migraine. No change. Stared IV and received migraine medicine that way. about 6 hours later migraine ebbed enough to go home. Continued with severe headache another 3 days  or so.
No additional AE reported; PNEUMOVAX 23 was administered to the patient after the excursion occured; This spontaneous report was received from a registered nurse referring to an unknown age and gender patient, whose medical history, concurrent conditions, previous adverse drug reaction, allergies, and concomitant medications were not provided.  On 15-MAR-2022, after an excursion took place, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), injection, administered for prophylaxis (lot number: U021995 with an expiration date: 13-JAN-2023 was verified to be a valid lot number; strength, dose, frequency, anatomical injection site, and vaccination scheme were not provided) (product storage error).  The dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was stored in a temperature of 0 degrees Celsius (C) for 24 hours. It was reported that there was a previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA006770: US-009507513-2206USA006587:
Presented to ED; SOB x10 days, N/V, productive cough; fever, fatigue; + covid at MD office PTA; - covid at hospital; DX: Covid PNA; thrombocytopenia & leukopenia (possible due to covid infection) Initially on 6L O2; CXR: clear; CT ith min nodular infiltrate in RUL; Labs: D-dimer: 8.53; CRP 2.22; Ferritin 895.61; TX: Lovenox, Decadron, Singulair, Zinc (not a candidate for remdesivir since no confirmed + covid test); remained on O2 via NC during stay and back to room air at time of d/c
Information has been received from a physician concerning a 7 month old female patient who on 11-MAY-2010 was vaccinated with the first dose of ROTATEQ (Lot # 665273/0204Z, expire date not reported), per oral. On 31-AUG-2010, the patient was vaccinated with the second dose of ROTATEQ (Lot # 667991/0726Z, expire date not reported), per oral. Suspect secondary therapy included third dose of ROTARIX (Lot # A41FB098A, expire date and route not reported) administered on 22-OCT-2010, first dose of Hib conj vaccine (manufacturer unknown) and first dose of hepatitis B vaccine (manufacturer unknown) both administered on 11-MAY-2010, second dose of Hib conj vaccine administered on 31-AUG-2010, second dose of hepatitis B vaccine (manufacturer unknown) and third dose of Hib conj vaccine both administered on 22-OCT-2010. Concomitant vaccines included DTAP, poliovirus vaccine and PREVNAR. Physician stated that on 03-JAN-2011, the patient was admitted to the hospital and was diagnosed with intussusception. Physician added that a barium enema was successful in releasing the intussusception. The patient recovered and on 06-JAN-2011, the patient was discharged from the hospital. This is one of two reports from the same source. Additional information has been requested.
(L) arm rash, swollen. Felt warm. Pt was given BENADRYL and KENALOG.
Infant became hypo-tonic, he couldn't hold is head up as normal, head was flopping to both sides.  His motor control was decreased for several weeks.
muscle weakness, stiffness, swelling, poor coordination, and muscle atrophy in the hands, shoulders and hip girdle muscles
urinary tract infection; This is a spontaneous report from a contactable consumer reporting for herself. An elderly female patient of unknown age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on 02Feb2021 as single dose for covid-19 immunization. Medical history included allergies to cats and dogs, and osteoporosis. The patient's concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot# EN5318 and expiration date not reported) dose 1 on an unspecified date for covid-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications in two weeks. The patient experienced urinary tract infection on 03Feb2021. AE resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measure taken as result of event: treatment included Nitrofurantoin Mono/Mac. On an unspecified date in 2021, the patient had resolved from the event.  Follow-up attempts completed. No further information expected.