chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 07-MAY-2018 and 10-JUL-2018, the patient was vaccinated with an improperly stored dose of VAQTA, lot # N026997, expiration date 10-NOV-2018; and ROTATEQ, lot # R002060, expiration date 05-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees (also reported as "max 55 degrees") Fahrenheit for 30 minutes and above 32 up to 35 degrees Fahrenheit for 16 hours (also reported as "brief intervals of being too cold lasting for 30 minutes each, ranging from 34 to 35.6 degrees Fahrenheit"). Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1807USA009780: US-009507513-1808USA006765: US-009507513-1808USA006766: US-009507513-1808USA006767: US-009507513-1808USA006768: US-009507513-1808USA006769: US-009507513-1808USA006770: US-009507513-1808USA006771: US-009507513-1808USA006773: US-009507513-1808USA006774: US-009507513-1808USA006775: US-009507513-1808USA006776: US-009507513-1808USA006777: US-009507513-1808USA006778.
Patient developed lump in right thigh following administration of vaccination. Lump is slowly decreasing in size. Patient is not bothered by lump. Ultrasound of lump was not concerning.
The shot itself made my arm hurt horrible,; still bad sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In August 2022, the patient received Shingles vaccine. In August 2022, less than a day after receiving Shingles vaccine, the patient experienced pain in arm and pain. On an unknown date, the outcome of the pain in arm and pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-AUG-2022 Reporter's comments; This case was reported by a patient via interactive digital media. He/she just had his/her first vaccine and was not sure if He/she will do the second one. The shot itself made his/her arm hurted horrible and it had been 24 hours now and it was still bad sore. Additional supportive information: Follow-up would not possible, as no contact, details were available.
Administered in right thigh. Four hours after administration he was unable to bear weight on legs. In severe pain. Symptoms lasted more than 24 hours. Also ran fever of 101. Seen by Dr. at the ped. office. Diagnosed vaccine reaction. Advil administered.  Prevnar was vaccine that caused the reaction.
swelling & redness @ site of inject; fever but not measured until 26AUG93 @ 345PM 100.9 ear; tingling in arm & fingers which started day p/inject; h/a, stomach-ache, generally not feeling well;
This spontaneous report as received from a Licensed Practical Nurse referring to a unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On unspecified dates, the patients were inadvertently vaccinated with improperly stored of ROTATEQ orally, lot # L008057 with expiration date: 01-DEC-2016 and lot# L027076 with expiration date: 25-MAY-2017 (dose number and dose were not provided). No adverse event was reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is expected since as there is not consent to follow-up.
Sensitive to light for 48 hours. My left arm hurts at the elbow and my back and legs are stiff after I have at for over 30 minutes.
CHRONIC HYPOTENSION 1/6/2022 ATRIAL FIBRILLATION, UNSPECIFIED CHRONIC RESPIRATORY FAILURE 3/11/2022 ATRIAL FIBRILLATION, UNSPECIFIED HYPOXIA 1/6/2022 ATRIAL FIBRILLATION, UNSPECIFIED CHRONIC HYPOTENSION 1/6/2022 SKIN OR SUBCUTANEOUS TISSUE ABSCESS CHRONIC RESPIRATORY FAILURE 3/11/2022 SKIN OR SUBCUTANEOUS TISSUE ABSCESS HYPOXIA 1/6/2022 SKIN OR SUBCUTANEOUS TISSUE ABSCESS CHRONIC HYPOTENSION 1/6/2022 NONTRAUMATIC ACUTE KIDNEY INJURY CHRONIC RESPIRATORY FAILURE 3/11/2022 NONTRAUMATIC ACUTE KIDNEY INJURY HYPOXIA 1/6/2022 NONTRAUMATIC ACUTE KIDNEY INJURY CHRONIC HYPOTENSION 1/6/2022 BACTEREMIA CHRONIC RESPIRATORY FAILURE 3/11/2022 BACTEREMIA HYPOXIA 1/6/2022 BACTEREMIA CHRONIC HYPOTENSION 1/6/2022 HX OF HEART TRANSPLANT CHRONIC RESPIRATORY FAILURE 3/11/2022 HX OF HEART TRANSPLANT HYPOXIA 1/6/2022 HX OF HEART TRANSPLANT CHRONIC HYPOTENSION 1/6/2022 NONTRAUMATIC ACUTE KIDNEY INJURY CHRONIC RESPIRATORY FAILURE 3/11/2022 NONTRAUMATIC ACUTE KIDNEY INJURY HYPOXIA 1/6/2022 NONTRAUMATIC ACUTE KIDNEY INJURY CHRONIC HYPOTENSION 1/6/2022 CHEST PAIN CHRONIC RESPIRATORY FAILURE 3/11/2022 CHEST PAIN HYPOXIA 1/6/2022 CHEST PAIN
Information has been received from a nurse practitioner via a company representative referring to a female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown. On an unknown date, the patient completed the GARDASIL 9 (route, strength, dose, batch/lot # and expiration date were not reported) for prophylaxis, per vaccination schedule. In approximately August 2018 (reported as "about 2 months ago), the patient saw the nurse practitioner, who performed a Pap smear on the patient. The result of the Pap-smear tested was positive for cancer (described as "one of the strains contained in the vaccine"). The patient had unspecified cancer (checked yes) on an unknown date. The outcome of the events was reported as not recovered. The causality was not provided. Upon internal review, the event of cancer was determined to be medically significant.
Patient stated he could not walk in the morning and this lasted for about 12 hours after the second dose of Moderna.
Patient received Moderna vaccine and is age 17.  No symptoms reports, but this vaccine is approved for those over age 18 only at this time.
large lump on her arm that is very hot, itching and hard; large lump on her arm that is very hot, itching and hard; large lump on her arm that is very hot, itching and hard; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (large lump on her arm that is very hot, itching and hard), FEELING HOT (large lump on her arm that is very hot, itching and hard) and PRURITUS (large lump on her arm that is very hot, itching and hard) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, LORAZEPAM, FISH OIL, VITAMIN B COMPLEX, FOLIC ACID (FOLATE) and CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) for an unknown indication.   On 28-Feb-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) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced INDURATION (large lump on her arm that is very hot, itching and hard), FEELING HOT (large lump on her arm that is very hot, itching and hard) and PRURITUS (large lump on her arm that is very hot, itching and hard). The patient was treated with BENZETHONIUM CHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (CALAGEL) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INDURATION (large lump on her arm that is very hot, itching and hard), FEELING HOT (large lump on her arm that is very hot, itching and hard) and PRURITUS (large lump on her arm that is very hot, itching and hard) had not resolved.
No other AE/PQC reported.; temperature excursion on PROQUAD; This spontaneous report was received from an other referring to a 4-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, current condition, previous drug reaction or allergy and concomitant medication was not reported.  On 05-MAR-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status of rHA, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot # T013537, expiration date 17-OCT-2021) for prophylaxis. The vaccine administered experienced temperature excursions of -6.7 degrees Celsius for 2 hours as recorded by a data logger. There was no previous temperature excursion. No additional adverse event reported.
VOMITING; ARM SORENESS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced vomiting. On MAR-2021, the subject experienced arm soreness. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, arm soreness, and fever on MAR-2021. This report was non-serious.
Pt has been in hospital since 12/23/21 with abdominal pain and abdominal abcess, sepsis d/t diverticulitis. Was a rapid response call on 1/13/2022 for respiratory distress, hypoxia requiring high flow oxygen.
This spontaneous report was received from a physician via company representative refers to a 84 year old female patient. Medical history and current conditions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, frequency, indication, route of administration were not reported). Concomitant therapy was not reported. On an unknown date, the patient was diagnosed with herpes zoster on her face, near an unspecified eye and on the back of the neck and experienced a lot of pain an unspecified period of time after receiving ZOSTAVAX. The treatment was given for adverse event. The patient sought medical attention. The outcome of herpes zoster and pain was unknown. Causality assessment was not reported. Additional information has been requested.
Patient was administered a Bivalent Moderna COVID vaccine as her first COVID vaccine series dosage in error instead of the Monovalent Moderna recommended as the first dose in the series. No adverse reaction to the vaccine was noted. Patient will be notified and offered to have Monovalent Moderna first dosage administered to start the series.
Ringing in ears for 24 hours; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8737) via an unspecified route of administration in the left arm on 31Mar2021 at 08:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 31Mar2021 at 11:45, the patient experienced ringing in ears for 24 hours. The adverse event did not result in a visit to the doctors or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event ringing in ears were recovered on 01Apr2021 at the time of this report.    No follow-up attempts are needed. No further information is expected.
Day 3 - Chills, Thirsty, Tired Day 10 - Day 3 through 10 fatigue, with the worse being day 10. Slight headache, slight leg, thigh, shin pain after short walk. Still tired, with slight weakness 3 weeks after vaccine.
covid vaccine 3/31/2021 Pt reports left leg pain 4/1/2021 Pt went to PCP (myself) 4/5/2021 and c/o left calf pain x 1 week  Ordered venous duplex Lower extremity left leg  Pt went to ultrasound radiology 4/7/2021 Same day referred to ER for treatment/Referred to  ER given complex history indication for IV heparin Pt went to ER 4/8/2021, Patient received 1 dose of LMWH and then started on apixaban -induction, then maintenance therapy.   Seen for follow up 4/28/2021 outpatient
pt was vaccinated and made it to observation. pt was greeted by nurse and sked if he was ok. pt states he was fine.  pt then stated he started to see stars and woke up on the ground from his chair.  pt states he does not remember passing out.
Developed Shingles rash; rash; This is a spontaneous report from a contactable healthcare professional. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via intramuscular route of administration in the left arm on 06Apr2021 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid. The patient previously received cyanocobalamin (VITAMIN B12) on an unspecified date for an unknown indication and experienced drug allergy. Concomitant medications included levothyroxine sodium (SYNTHROID) from an unknown date for unspecified indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Apr2021 the patient had developed Shingles rash, almost 2 weeks following first dose. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with Valtrex. The clinical outcome of the event Shingles rash were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Pt. called to report hives on arms, bilatterally. States areas are itching and burning.
Patient reports that she developed pain left shoulder after receiving vaccine and has not been able to lift arm due to severe pain since.
Sore arm x 3 days, low grade temperature to 99.8 from about 2 hrs to 7 hrs after, myalgia, flulike feeling.
Information has been received from a physician's office staff concerning a 92 year old female who on 01-NOV-2007 was vaccinated with a dose of ZOSTAVAX (no lot# provided).  On approximately 01-NOV-2007 the patient called the physician's office "within 24 hours" after vaccination because the patient's face was swollen and she developed a rash all over her body.  Per office staff, the patient was brought to the emergency room on 16-NOV-2007 and because of the rash all over her body.  On approximately 16-NOV-2007 a culture of the rash was performed which showed the patient was positive for "herpes cytopathic."  The outcome was unknown.  There was no product quality complaint.  Additional information has been requested.
Presented for fall at home. Recently dx w/urotelial CA. Admit for COVID PNA. Hx of DM, HTN, CKD, CVA. Tx w/abx, steroids, remdesivir, supplemental O2. Weaned to RA at time of DC. DC'd home.
Sore throat, cough, body aches, congestion, loss of smell, headache and trouble sleeping.
COVID-19 pneumonia; Fever (body temperature at 102.7 Fahrenheit); Threw up; littles scratchy throat; Cough; Sore throat; Dizzy spells; Runny nose /nose was a faucet; Little sore arm; Fatigue; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient).   A 48-year-old female patient (weight: 148.32 kg, height: 170 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL9262) intramuscularly, in the left arm, at single dose, on 28Jan2021, at 13:30, for COVID-19 immunisation. Relevant medical history included light Crohn's disease from an unspecified date. Concomitant medications included oral fexofenadine hydrochloride (ALLEGRA) 60 mg, twice daily (60 mg, 1 tablet every 12 hours), from 02Feb2021 to 05Feb2021, for nasal congestion; oral paracetamol (TYLENOL, capsule) 500 mg capsule (she took 2 as needed), from 02Feb2021 and ongoing, for fever and headache; salbutamol (ALBUTEROL) 90 mcg, 2 puffs every 4-6 hours as needed, from 06Feb2021 and ongoing, for breathing problems and oral benzonatate 100 mg, thrice daily (100 mg capsules, 1 by mouth three times daily as needed) from 06Feb2021 and ongoing, for cough. On an unspecified date, in Feb2021, the patient developed little sore arm and fatigue. On 01Feb2021, the patient experienced runny nose, nose was a faucet. On 02Feb2021, she had little scratchy throat, cough, sore throat and dizzy spells. On 04Feb2021, she threw up and on 05Feb2021, the patient experienced fever (she had temperature at 102.7 Fahrenheit) and then was hospitalized. Post the vaccination, the patient has been tested for COVID-19 on 05Feb2021 and resulted positive and pneumonia requiring hospitalization. She was admitted on the 05Feb2021 discharged on the 09Feb2021. Chest x-ray and CT chest performed on 05Feb2021 showed pneumonia. Body temperature on 05Feb2021, at night, was 102.8 Fahrenheit. Oxygen saturation (pulse ox) showed the following value: 80s, 84 and 93 on an unspecified date, in Feb2021. Emergency Room Visit and Physician Office Visit required for runny nose, throat irritation, cough, sore throat and pneumonia. Treatment was received for COVID-19 pneumonia, fever, runny nose, throat irritation, cough and sore throat. She was supposed to get the second vaccine on the 18Feb2021. The patient recovered from fever on 07Feb2021, did not recover from dizzy spells, while clinical outcome of the other events was unknown at time of this report.
Report itchiness and redness at the injection site.  Treatment: None, Outcome: Has improved,  recommend OTC hydrocortisone and/or OTCH oral antihistamine. Did not interfere with ADLs.
p/vax mom observed 2 x 1 1/2 inch diameter red, swollen area on inner aspect of lt leg @ site of knee;given DPH c/o itching area;elbow observed 1 1/2 x 1 red swollen area;
FELT SLIGHTLY WEAK FOR FIRST TWO DAYS AFTER VACCINE.  THIRD DAY NASEAU, SEVERE HEADACHE, EXTREME FATIGUE SET  IN.  COULD NOT EAT OR DRINK MUCH OF ANYTHING FOR 2-1/2 WEEKS.  HAD PCP CALL IN SCRIPT FOR NASEAU AND HEADACHE.  HEADACHE STOPPED AFTER A LITTLE OVER A WEEK.  NASEAU PERSISTED.  WENT TO URGENT CARE ON NOVEMBER 2.  GOT BAG OF IV FLUIDS AND WAS DISCHARGED.  WENT TO EMERGENCY DEPARTMENT ON NOVEMBER 4 DUE TO PERSISTENT NASEAU, DEHYDRATION AND BACK PAIN.  RECEIVED 2 BAGS OF IV FLUID, SOMETHING FOR NASEAU AND A DOSE OF MORPHINE FOR BACK PAIN.  WAS DISCHARGED.  CAREGIVER SAID SHE THOUGHT THERE WAS AN AUTOIMMUNE COMPONENT TO MY SYMPTOMS.  WENT BACK TO EMERGENCY DEPARTMENT ON NOVEMBER 6.  WAS GIVEN 60MG PREDNISONE AND PRESCRIBED 40 MG FOR FIVE ADDITIONAL DAYS.  IT APPEARED THAT THE COVID VACCINE TRIGGERED AN AUTOIMMUNE FLARE.  DISCHARGED.  PREDINSONE APPEARS TO BE HELPING.  FOLLOW UP WITH RHEUMATOLOGIST AND GASTROENTEROLOGIST ON NOVEMBER 8.   SOME LABS STILL OUT OF NORMAL RANGE.  WAITING FOR INSTRUCTIONS FROM PHYSIAN ON NEXT SEPS
From ~8:30pm on Friday 2/5/21 till ~1:30pm Saturday 2/6/21, I experienced chills and slight fever, simultaneous restlessness/agitation and exhaustion, and an intermittent feeling of electric "flow" running through my body; I did not feel "in my right mind" and had trouble thinking straight.  For the following week, through Thursday 2/11/21, I felt unusually cold (e.g. the heat was on 71 degrees at work and my hands were blue), and I experienced occasional "brain zap" sensations.
He called out sick yesterday 1/7, but he did come into work today and is stilling feeling horrible with diarrhea and stomach cramps, sent home, scheduled for covid testing 1/9
One hour after injection I had pain in my right shoulder, trouble sleeping, and constant pain. On the fourth day the constant pain subsided but I could not raise my arm above my shoulder without pain and even at rest I still have pain. As of today 10/29 I still can't raise my arm without pain.
This is a 75-year-old male with a past medical history of advanced dementia, BPH, seizure disorder who presents for COVID and fever.  Patient has had decreased appetite and not taking p.o. recently so they sent him to the emergency room.  I have attempted to reach his daughter but no in his answered the phone, therefore I left a telephone message. Patient himself is nonverbal therefore all my information is being taken from ER records.  We have minimal information except for his medications.  There is no information regarding his code status.  In the emergency room he had a temperature of a 100.2° and found to have COVID pneumonia but he is not hypoxic at this time. He has mild renal failure with a BUN of 33 and creatinine of 1.3.  His baseline is unknown.
Pink, spotty rash on bilateral arms and legs. Flat. Not itchy or painful.
pt was playing & went limp & heart rate dec x 20min per mom;mom states no fever or other problems prior to episode;taken to ER in care to NE georgia hosp in gainesville;adm-heart monitor placed on pt IV started secondary dehydration;
Information has been received from a medical assistant referring to a 6 month old female patient. No relevant medical history or concurrent conditions were reported. On 30-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports  received from the same reporter. Additional information has been requested.
This spontaneous report as received from the office manager refers to a 12 month old female patient. Pertinent medical history was unknown. On 02-DEC-2014 the patient was vaccinated with M-M-R II (lot#H01A4A4, Expiry date: 10-May-2014, anatomical location was reported as left leg, frequency was reported as once, route of administration and therapy type was unknown) which was expired. Concomitant medications were unspecified by reporter. It was unknown of there was any relevant laboratory data. The outcome of the event was unknown. The reporter also stated that it was unknown if the patient would receive another M-M-R II. Additional information has been requested.