chrisvoncsefalvay/vaers-outcomes huggingface dataset:
UTI; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 13Oct2021 15:00 (Lot number: EW0217) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Endometriosis", start date: 2018 (unspecified if ongoing), notes: Verbatim: Endometriosis since 2018; "COVID-19" (unspecified if ongoing), notes: Verbatim: If Covid prior vaccination: Yes. Concomitant medication(s) included: PROBIOTIC GUMMIES; FISH OIL. Past drug history included: Ceclor, reaction(s): "Rash", notes: Verbatim: Ceclor- when I was a baby I got a rash. The following information was reported: URINARY TRACT INFECTION (non-serious) with onset 29Oct2021, outcome "recovered" (2021), described as "UTI".  Additional information: Prior to vaccination, the patient was diagnosed with covid-19 and post vaccination, the patient had not been tested for covid-19. The patient did not receive any other vaccine in four weeks. Concomitant medications (also reported as other medications in two weeks) noted as womens multi-vitamin. It was reported that patient got UTI (urinary tract infection) 16 days after the first dose of the vaccine and it took 23 days to go away also patient was concerned that was from the vaccine. Device timestamp noted as 21Nov2021.  No follow-up attempts are possible. No further information is expected.
About 3 hrs after the first dose, I had full body itching, severe chills, body aches, a severe headache, some swelling in my right arm with a red circe that lated about two weeks, lost all the skin on my hands both inside and out. This happened with both doses.
After waiting 30 minutes for observation, patient reported itching and redness in neck. Pharmacist gave patient oral Benadryl and observed patient. Patient symptoms resolved and patient left 1 hr later with husband. Pharmacist educated patient to seek medical treatment if symptoms appear again and worse such as trouble breathing.
Numbness in left hand arm and face, body aches, headache, and vertigo dizziness-Central Nervous system impact--- as I am putting in this request  in on this site and (I do not know when that will stop on 2nd shot of Moderna it lasted a full month.) fever ranging from 99 to 101. Pain at injection site large red rash at injection site and a hard knot at the place of injection site have to rub it every day to move the medication out of the injection site location.
hot to the touch/burning; Rash on hip; A spontaneous report was received from a consumer, concerning a female patient of 71 years of age, who received Moderna's COVID-19 vaccine and experienced rash on her hip, hot to touch/burning/ dry skin.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an 17-FEB-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis..  On an 17-FEB-2021, after first dose of vaccine, the patient experienced rash on her hip . On an 18-FEB-2021  the patient experienced hot to touch/burning/ dry skin. No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was unkown.  The outcome of the event, rash on her hip, hot to touch/burning/ dry skin was considered to be not resolved at the time of this report.
Information has been received from a consumer, concerning her brother, a male patient of unknown age. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On an unknown date, the patient was vaccinated with an unspecified dose of M-M-R II (strength, dose number, dose, anatomical location, route of administration, lot number and expiration date were not provided) for routine vaccination (prophylaxis). On an unspecified date, the patient experienced swelling and a rash all over his body and a fever that was 104F and lasted for a week. At the time of the report, the patient was recovered from the fever, and the outcome of the patient regarding swelling and a rash all over his body was not reported. The consumer considered the adverse events to be related to M-M-R II since the reporter consider this as a really badly reaction to the M-M-R II. This is one of three reports received from the same reporter. Additional information is not expected since there reporter did not consent for further follow up. Sender's Comments: US-009507513-1706USA004400: US-009507513-1706USA003434.
Patient is 14 years old and given a Moderna vaccine.  Mom was notified.  This was given by a MA.  Has been trained previously and now retrained.
upper left arm was very painful from 3 pm of the day I got the shot until 4 days later.  I could hardly move it and had to take sleeping pill at nite.
Chief Complaint Patient presents with ? BLOOD PRESSURE     coming from facility round 10am, staff went to check on him and he was only responding to painful stimuli, baseline A&O3. Found to be hypotensive by EMS 50s/30s  ? Altered Mental Status     Patient presents via EMS from his nursing facility for altered mental status. He was last seen as normal at 10 AM. Patient had an appointment with his doctor but when they went in to check on him he was minimally responsive. He is normally a and O ×3. He was found to be hypotensive by EMS. No fever. No known trauma or injury. Upon arrival his blood pressure improved. No other acute issues, symptoms, complaints. Patient is unable to provide a history. 5/5/2021 admitted to the hospital tested + for Covid 19
autoimmune hemolytic anemia & immune thrombocytopenia which worsened rapidly post-vaccine symptoms - bleeding, short of breath, incredibly tired, pale, weak - symptom onset 8 hours post-vaccine rapid progression for first 24 hours post-vaccine)  blood transfusion, platelet transfusion, treatment with steroids' (still undergoing treatment and seeing no improvement at this point)
COVID-19; COVID-19; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "Depression in remission" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: ESCITALOPRAM; TOPIRAMATE; RIZATRIPTAN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included nirmatrelvir/ ritonavir (PAXLOVID) from 09Sep2022 to 14Sep2022; completed 5-day course of PAXLOVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
A Spontaneous case report was received from a consumer who was a female patient who has received first dose of Moderna COVID-19 Vaccine (mRNA-1273) on 22-JAN-2021.She experienced her feet was really cold.Past medical history was not provided.Treatment wa unknown.The outcome of the patient is unknown.
Pt recv vax on 12/17/98; on 12/18/98 pt exp red, pain at vax site, fever & headache
Left thigh cellulitis at site of DTAP injection. Mother reports that normal/usual skin prep was done before injection. Clinical exam; there was an expanding area of erythema, edema, tenderness and warm to touch. Clinical dx cellulitis. Pt given oral antibiotics.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT SYNDROME ACUTE PULMONARY EMBOLISM CHRONIC HYPOXEMIC RESPIRATORY FAILURE
broke out in hives; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2021, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received a dose of Shingrix vaccine last month and broke out with hives. The patient enquired if he/she should have the second dose or not. Follow-up would not be possible as no contact details available.
Dry cough; Throwing up; My stomach was not right for a couple days; Tested positive for Covid; Tested positive for Covid; Headache; This is a spontaneous report received from a contactable consumer (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date in Feb2021 as DOSE 1, SINGLE and dose 2 via an unspecified route of administration on an unspecified date in Feb2021 as DOSE 2, SINGLE both for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Sep2021, the patient tested positive for covid. On 01Sep2021, patient had headache. On an unspecified date, the patient experienced dry cough, throwing up, my stomach was not right for a couple days. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 03Sep2021. The outcome of the event tested positive for covid was unknown and other events outcome was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This is in follow-up to report(s) previously submitted on 2/13/2007. Information has been received from a physician and physician assistant concerning a 1 year old male patient who on 18-JAN-2007 was vaccinated IM in the thigh with a dose of Zostavax (Merck) (lot # 652947/1411F) instead of Varivax (Merck). Concomitant vaccination included a dose of MMR II (lot # 651803/0631F) given IM in the thigh and PROHIBIT (manufacturer unknown) (lot # UE976AE) given IM in the thigh. The physician reported that there was no product confusion, "it was human error." No adverse reaction noted. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. Additional information indicated there were no adverse symptoms. No further information is expected.
This case was reported by a nurse via sales rep and described the occurrence of cellulitis of arm in a 79-year-old female patient who received HAVRIX 1440 adult. Co-suspect products included Typhoid vaccine. On 29th December 2016, the patient received the 1st dose of HAVRIX 1440 adult 1 ml and Typhoid vaccine. On 30th December 2016, 1 days after receiving HAVRIX 1440 adult and Typhoid vaccine, the patient experienced cellulitis of arm (serious criteria GSK medically significant) and pain. The patient was treated with antibiotics nos. On an unknown date, the outcome of the cellulitis of arm and pain were unknown. It was unknown if the reporter considered the cellulitis of arm and pain to be related to HAVRIX 1440 adult and Typhoid vaccine. Additional details were provided as follows: The reporter did not know where the site of injection was, but both vaccines were given on the same arm. The nurse reported that the patient received 2 courses of antibiotics. No other information was provided.
I started to have GI problems eight days after getting the third dose of the vaccine. I had diarrhea and it has been consistent for five weeks after the vaccine. I have tried diet modification and it helped but it is still unpredictable. I went to the doctor because I had some swelling under my right arm. I had had the swelling for a couple of weeks before the booster.
Pt was given Pneumovax 0.5cc IM right deltoid.  Within 24 hours, developed redness and gross swelling at injection site with fever 100 degrees.  Ice applied. Consecutive treatment and observation.
One day post vax, the pt experienced a post vax rash. Twenty days later the owner of the day care center the child attends developed chicken pox and was covered with lesions. The day care owner had a history of chickenpox as a child. Additional information has been requested.
pt recvd vax 3-4 hrs later felt funny & could get a super deep breath; 3 hrs later seen by MD;dx as resp react; tx w/ dph & poss epi;resolved w/in 48 hrs;
Chest pain radiating into the back; nausea; vomiting; diarrhea; received first dose of BNT162B2 on 04Jan2021, received second dose on 19Jan2021; This is a spontaneous report from a contactable other HCP (Parent). A 29-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number-EL3248), intramuscular on 19Jan2021 12:00 at SINGLE DOSE in Left arm for COVID-19 immunisation. The patient was not Pregnant at Time of Vaccination. Facility type vaccine was Hospital. Medical history was none. Comcomitant medications in two weeks included birth control. No other vaccine in four weeks. The patient previously received first dose of BNT162B2 (lot number- EK9231), intramuscular on 4Jan2021 10:00 at SINGLE DOSE in Left arm for COVID-19 immunisation. The patient experienced Chest pain radiating into the back, nausea, vomiting, diarrhea on 20Jan2021 05:45 AM. AEs Chest pain radiating into the back, nausea, vomiting, diarrhea Resulted in Emergency room/department or urgent care. The outcome of Chest pain radiating into the back, nausea, vomiting, diarrhea was Recovered in Jan2021, of other event was unknown. No treatment for events Chest pain radiating into the back, nausea, vomiting, diarrhea. Unknown if covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Intense pain in (R) arm. Any movement of arm flexion/extension resulted in increased pain. Seen by neuro had EMG of (R) upper extremity. Clinically felt to be c/w post vaccinal neuritis of (R) arm despite normal EMG.
On 07/11/2001 the patient experienced a runny nose, fever of 101-102F. Night terrors started on 07/10/2001. The patients joints, arms, sometimes legs and hands were tingling. The patient doesn't want anyone to touch him.
Patient recieved Pfizer booster shot vaccination with her husband in the passenger seat, who did not receive a vaccination. After the shot they drove to observation, parked the car and shortly after patient passed out for "no more than 30 seconds" husband reported. Paramedics on site were called to assist. At that time she was responsive, pupils equal and reactive and talking to paramedics. Blood pressure reading initially read 53/36 with a heart rate of 44 with blurry vision. at 1442 blood pressure 111/75, HR 84, SPO2 97% respirations 13. At 1455 BP 103/56, HR 79, SPO2 95% and respirations 12. Patient refused a blood glucose check.
I feel like pins and needles are all over my body; Tingling sensation; This is a spontaneous report from a non-contactable consumer, the patient.  A 26-year-old female patient received the unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 29Mar2021 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history included shingles 3 years ago. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021, the patient experienced tingling sensation that started immediately after vaccination and felt like pins and needles are all over the body. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. The clinical outcome of the events pins and needles and tingling sensation was not recovered at the time of the report.  No follow-up attempts are needed; information about the lot number cannot be obtained.
Died unexpectedly in 2008, shortly after receiving the Gardasil human papillomavirus (HPV) vaccine; This spontaneous report was received from a lawyer via social media referring to a 21 years old female patient. Information about medical history, concurrent conditions, drug reactions/allergies and concomitant therapies was not provided.  On an unknown date in 2008, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (vaccine dosage detail, route of administration, lot# and expiration date were not reported) for prophylaxis. The patient died unexpectedly shortly after receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The reporter considered death unexpectedly to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).
On 10-12-07 Fri. red around mouth about 5:30 pm, spread within hour hives on arms, legs, trunk after Friday evening. Started improving. Better Sat morning. Gave antihistamine, generic Zyrtec. Couple hives chin Sat. By Sunday much improved. Clear today, Monday 10-15-07.
This spontaneous report as received from a licensed practical nurse refers to a newborn infant. The patient was vaccinated intramuscularly with dose 1 and 2, 0.5 ml RECOMBIVAX HB (lot# not reported) on 16-OCT-2012. The doses were given a few hours apart. No other co-suspects were reported. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
No additional adverse event; the patient was inadvertently administered a dose of ROTATEQ on 4/2712020 that had been improperly stored; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender.  The patient's concomitant therapies, concurrent conditions and medical history were not provided.  On 27-APR-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) orally, lot # 1660947, expiration date 16-FEB-202,1 for prophylaxis.        Temperature: 47.7F Time frame: 12 MINUTES Previous temperature excursion? 58.3F 14 HOURS Was call because ofa "data logger"? YES
Date of 10/15/06 was taken to hospital unresponsive and foaming at the mouth. Had received 5 rabies vaccinations between 8/03/06 and 8/31/06 to be collected as hyperimmune Plasma. 01/23/07-records received and reviewed for DOS 10/15-10/20/06 DX: Coma after possible prolonged seizure versus anoxic injury versus infectious process.  Arrived in ER unresponsive. PMH:lives in group home drug rehabilitation house. Found unresponsive foaming at the mouth. EMS arrived Narcan given. Previous drinking a few days prior. History of drug abuse. Question of him taking medications belonging to another resident. 01/23/07-records received and reviewed for DOS 10/15-10/20/06 DX: Coma after possible prolonged seizure versus anoxic injury versus infectious process.  Arrived in ER unresponsive. PMH:lives in group home drug rehabilitation house. Found unresponsive foaming at the mouth. EMS arrived Narcan given. Previous drinking a few days prior. History of drug abuse. Question of him taking medications belonging to another resident.  01/25/07-spoke with RN vaccine provider, date of adverse event was 10/15/06, correction made in VAERS. Reason for administration of rabies vaccine is to hyperimmunize plasma donors. This plasma is used in speciality products. Per 60 day follow up: We were later informed that the recipeint was hospitalized because he tried to commit suicide, method was not disclosed to us.
Patient received his vaccination at an onsite clinic and administered by onsite nurse (at work). Patient had pain after the shot which steadily got worse. He was seen at our clinic on Feb 2016 complaining of shoulder pain after the injection. Got an intra-articular injection to the shoulder which didn't help.  Range of motion got severe restricted. He self-referred to a chiropractor in 2016 who treated it with what sounds like TENS unit, ultrasound and exercises. This improved the range of motion but pain is still present. Pain was a 10/10 initially; now down to a 5-6/10. Causes sharp pain with certain movements - affecting job as mechanic and interfering with rest/sleep.
Day 1-4 soreness at site, stiffness to Left Arm, Fatigue,  soreness to neck under ears  2 weeks after injection- large swollen, reddened itchy area around injection site size of coffee cup top
Arm Soreness; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd April 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm and fatigue. On an unknown date, the outcome of the pain in arm and fatigue were unknown.   It was unknown if the reporter considered the pain in arm and fatigue to be related to Shingrix.  Additional case details were reported as follows: The patient had fatigue and arm soreness. This case had been linked to the case US2019073321, reported by same reporter. The reporter consented to follow up.
24 hours after shot #1 I had a fever of 100 F and diarrhea. Fever subsided 12 hours later. Diarrhea subsided after one episode.
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and, concomitant medications were not reported. On 21-FEB-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
No signs or symptoms were reported; Temperature excursion on ROTATEQ that ocurred on 02-AUG-2021. ROTATEQ was administered to a patient on 27-AUG-2021; This spontaneous report was received from an unspecified reporter (other), referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 02-AUG-2021, the Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ) had a temperature excursion of 8.882 Centigrade degrees (°C) for 7 hours 12 minutes. A previous temperature excursion was not reported.   On 27-AUG-2021, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ) orally, 1 time dose, lot# 1741375, expiration date 05-MAR-2022, for prophylaxis (strength, dose and frequency were not reported). No signs or symptoms were reported.
Acute localized reaction to pneumovax within hours of injection patient experienced pain,redness and swelling, and warmth at the site of injection. 6-8cm diameter raised red flat patch of redness no fluctuation but tender.  No evidence of wheezing,shortness of breath,fever or mouth swelling.  Patient was advised to use ice at the site, ROM as tolerated, Tylenol or Vicoden for pain.