chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Registered Nurse and refers to multiple unspecified patients of unknown age and gender. Patients concurrent conditions, medical history and concomitant medications were unknown. It was reported that doses of PNEUMOVAX 23 Lot # L019836, expiry date 24-MAR-2017 (dose and route were not reported) that had been exposed to 34.4F for 2 hours and then back in the range, were given to unspecified patients on unspecified dates. It was also confirmed that the vaccine had no previous temperature excursion. It was unknown if the patients sought medical attention. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
The enclosed photos are the youngster with what is either a reaction to MMR or Varivax.  On 1/24/05 she received: Varivax, MMR, Comvax, IPV, DTaP.  She presented 2/4/05 with a rash of 2 days duration.  She also has eczema and no known phone number.  I will try to submit this to VAERS also.
Moderna COVID-19 Vaccine EUA 01/25/2021  1:00 AM  chills, 8-h (650mg) Tylenol 01/25/2021  6:00 AM  98F  nauseous  8-h (650mg) Tylenol 01/25/2021  1:00 PM  100F fever  8-h (650mg) Tylenol 01/25/2021  7:PM  fever, nauseous, emesis,   8-h (650mg) Tylenol 01/26/2021 7:00 AM diarrhea, but 98 F temperature  feel fine at 11:00 AM
Rash was evident on left arm as a large red splotch about a day and a half after injection and next morning noticed rash behind ears, on arm pits and under breasts.  Did not report anything and rash is now diminishing. No treatment done.
Vaccination site pain; This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On an unknown date patient experienced little twinge in arm after vaccination  No treatment medications reported
Patient experienced fevers, body aches, and abdominal pain x 2 -3 days after the vaccination.
little bit of a fever, around 99.9; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (little bit of a fever, around 99.9) and CHILLS (chills) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced PYREXIA (little bit of a fever, around 99.9) and CHILLS (chills). At the time of the report, PYREXIA (little bit of a fever, around 99.9) and CHILLS (chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.9 (Inconclusive) 99.9.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
pain to left arm, fever of 101 24 hours after injection, mild chills and body aches.
Pt vaccinated with DTP/OPV was very irritable & exhibited inconsolable crying, starting approx 10 hrs after the vaccine & continuing for most of the next day. Also fever of 101.
Pt c/o low libido and energy for 3 months.  Not exactly clear when sx started after 1st Moderna vaccine, sx were not immediate so he is not sure exactly how long after.  Pt also had COVID 3 months ago and reports relatively mild sx.  He was forced to get vaccine w/n 30 days.  Tested pos COVID 2 Aug 2021 and 1st moderna 16 Aug 2021, 2nd 10 Sep 2021.  Pt can get an erection if he tries; however, he has significant decrease in libido, which is effecting his relationship w/ his spouse.  Admits to fatigue which showed up at same time and loss of pleasure in doing things.  Moved to area 12 months ago.  No major career changes or stress changes.  Denies SI/HI.  He reports he is sleeping 7-8hrs/night.  Denies diplopia, myalgia, muscle weakness, numbness, paresthesia. No hematuria, urinary urgency, urinary frequency, pain w/ bowel movements, hematochezia, pain w/ ejaculation, testicular pain, testicular swelling.
had shot sat oct 23rd 10am. felt a pain under my left arm , below my  armpit, sunday morning,  oct 24th. i thought i  might have moved oddly and strained a muscle. still, pain, monday, oct 25th Looked online  on oct 26, moderna side effects, below armpit...they discussed lymph node swelling called my gynnee, left message with nurse
No adverse event on patient; Temperature excursion total time: 25 mins, 3 excursions on dates: 09-SEP-2022 for 8 minutes; 10-SEP-2022 for 5 minutes; 03-JAN-2023 for 12 mins; This spontaneous report was received from an office manager, referring to a 11-year-old female patient.   The patient's concurrent conditions, concomitant therapies and medical history was not provided.  Since 09-SEP-2022, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe doses experienced 3 temperature excursions as follows: on the same date for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 mins (product storage error). Excursions were not noted until after the fact due to employee error of cleaning data logger more than once a day.   On 08-MAR-2023, the patient was vaccinated at private's doctor's office/hospital with a dose of the aforementioned doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (administration sites, and routes of administration were not provided) and was administered by the ordering physician for prophylaxis. Involved lot numbers and expiration dates were: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023. This report was called because of a data logger. There were no issues, nor adverse event reported on patient.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
PT FELT LIGHTHEADED AND LOSS OF CONSCIOUS NESS FOR 10 SECONDS
Day 10 post vaccination, the right arm has a square red spot that is warm to the touch.
HEADACHE; NAUSEA; FEVER; STOMACH CRAMPS; VOMITING; REALLY BAD SHAKES; This spontaneous report received from a patient concerned a 22 year old female. The patient's height, and weight were not reported. The patient's past medical history included laparoscopic surgery, and concurrent conditions included endometriosis, and factor v leiden carrier, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, and expiry: 01-JUL-2021) dose was not reported, administered on 22-MAY-2021 10:30 to the left arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAY-2021, the subject experienced stomach cramps. On 22-MAY-2021, the subject experienced vomiting. On 22-MAY-2021, the subject experienced really bad shakes. On 22-MAY-2021, the subject experienced nausea. On 22-MAY-2021, the subject experienced fever. On 23-MAY-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 101.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 22-MAY-2021, and fever on 23-MAY-2021, was recovering from nausea, and stomach cramps, had not recovered from headache, and the outcome of really bad shakes was not reported. This report was non-serious.
Middle Ear Congestion; ringing in right ear; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EAR CONGESTION (Middle Ear Congestion) and TINNITUS (ringing in right ear) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and PREDNISONE for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Dec-2020, the patient experienced TINNITUS (ringing in right ear). On an unknown date, the patient experienced EAR CONGESTION (Middle Ear Congestion). At the time of the report, EAR CONGESTION (Middle Ear Congestion) outcome was unknown and TINNITUS (ringing in right ear) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had negative for past history of COVID-19 . Patient diagnosed with middle ear congestion.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Patient demographics is updated.Medical History is updated. Event list is updated.
A 73yo male with history of HTN, Multi vessel Coronary Artery Disease, Coronary Arteriosclerosis, BPH, Elevated PSA, DM, Shoulder Pain and PTSD He received Covid-19 vaccine first dose on March 11, 2021 AM and the second dose in April 8, 2021 AM per PCC Pharmacist's report on March 23, 2021, the patient had a historical ADR of Fatigue, Headache, Muscle Pain, SOB and Diarrhea, which occurred post the second vaccine shot and which lasted for 3 days.
SWELLING, REDNESS, WARMTH TO THE AREA OF INJECTION (4 INCHES IN DIAMETER AROUND THE SITE) THE NIGHT OF THE VACCINATION.  TREATED WITH ICE PACK AND ZYTREC.  THE NEXT DAY WAS STILL THE SAME.   A CIRCLE WAS DRAWN AROUND IT TO SEE IF IT WOULD SPREAD.   THE REDNESS AND SWELLING SPREAD OUTSIDE OF THE  LINE SO PATIENT WENT TO THE DR. OFFICE.  THEY SAID THEY THOUGHT IT WAS A REACTION TO THE VACCINE, AND THEY PRESCRIBED TRIAMCINOLONE CREAM AND CEPHALEXIN CAPSULES ON 9/5/19
twitching under her right eye on and off/twitching muscles underneath the eye; This is a spontaneous report from a contactable health care professional (pharmacist). A 31-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number was not reported), via an unspecified route of administration on 24May2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On May2021, the patient experienced twitching under her right eye on and off/twitching muscles underneath the eye. Pharmacist calling on behalf of his 31 year old female patient at the pharmacy to receive her second dose of the Pfizer Covid-19 Vaccine. Patient received her first dose on 24May2021. She experienced twitching under her right eye on and off after the vaccine. She was back for her second shot and she was worried that the second dose may cause a more severe reaction. She had not reached out to her HCP about her experience. Caller was asking has there been any reports of muscle twitching after the first dose, wanted to make sure it was not worse with the second shot. Within half hour after getting the dose, the patient experienced twitching muscles underneath the eye which lasted for 24 hrs. The patient has come back already today and was about to get her second dose after 38 days. She got the first dose last 24May2021. It was their first time hearing this side effect and wanted to know what they should do. The clinical outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.
22 y.o. female w/reax to smallpox vax. Hyper-pigmented irregularly shaped patches to chest and cover back. Increased itching, slight scaling lesions to back / urticaria. Meds: Benadryl, hydrocortisone.
Possible less diluent used in the Pfizer pediatric vaccine. I thought I used the 2.2 ml normal saline, diluent, for the maroon pediatric vaccine. After a 3rd dose of 0.2 ml taken from the vial, there was none left. There should have been a total of 10 doses. I did not remove 2.2 ml of air from the vial prior to injecting the 2.2 ml of NS. I have reached out to the families involved and they have reported that their child has not had any adverse reaction at this time. Harm is unknown at this time.
Patient states he started to feel poorly in the evening after receiving his injection. Symptoms included fever of 101, body aches. He took two Tylenol Flu and Cold pills to alleviate symptoms. The next morning he woke with body aches, fever resolved. He complained of some nausea and vomited after eating breakfast. States he had widespread body aches all of 05/24/2022. Body aches resolved evening of 05/25/2022. He states he feels fine now, no complaints. He did report that he was incapacitated by his symptoms, leading to him staying in bed all day on 05/24/2022.
Information has been received from a nurse practitioner concerning a 46 year old female who on an unspecified date had a varicella titer drawn which was negative, then on 29-NOV-2006 was vaccinated with a first dose of Varivax. On an unspecified date post vaccination, the patient developed a rash. It was reported that the client had 35 pox on unspecified locations on her body. Unspecified medical attention was sought. At the time of the report the patient's recovery status was unknown. There was no product quality complaint involved. No further information is available.
After the first vaccine, the significant fatigue began and has not improved, but has seemed to worsen. I have also had experiences with frequent episodes of memory loss and confusion. Have also experienced hair loss. I do not have the energy, stamina, or endurance to exercise and spend much of my time in bed.
Paxlovid  start on 14Apr2022 Treatment of COVID-19; Paxlovid  start on 14Apr2022 Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Oct2021 at 09:00 as dose 3 [booster], single (Lot number: FE3592) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Primary immunization series complete manufacturer unknown.), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Paxlovid  start on 14Apr2022 Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.
Patient's arm at injection site became very sore - muscle ws painful when touched - continues to be sore 10 days later and she hsa to restrict arm movement.
Information has been received from a physician via a company representative referring to a patient of unknown gender who was older than 26 years old. On an unknown date the patient was vaccinated with a dose of GARDASIL (strength: 120Y, dose, lot# and route were not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information is not expected because the physician would not like to be contacted.
Vasovagal event following administration of vaccine. Spontaneous resolution after being placed in supine position. Paramedics on site. No treatment required
Patient had pain, swelling and burning of arm and shoulder beyond what would be expected from pneumococcal vaccination.
Vaccine was administered by pharmacy worker, at approximately 11:30 on 9/3/2022. Staff did not swab the patient's arm with alcohol prior to injection. Primary symptom is neurological: Brain fog (ongoing), including difficulty recalling memories, concentrating, and finding the right word Brain fog started after experiencing a sudden, brief, and painful pressure in the center of the brain approximately 6 hours after vaccine administration.  Physical symptoms started gradually the day of the vaccine and gradually dissipated over the next several days (soreness/stiffness in arm, neck, back, passing chest discomfort)
9/18/12 ER visit - Dx febrile seizure, temp 103.6. TYLENOL for fever. RSV, Flu, Ua, CXR - negative. MRI (brain) - no seizure focus identified, no areas of abn enhancement. Admitted to pediatric unit.
left arm is extremely swollen and red. Unable to use it. Exception typing this form. This was the result from a pneumonia vaccine received 24 hours ago. I have had a penumonia vaccine 5 years ago with no reactions. I have taken Advil and used ice to reduce the swelling, with no results.
SICKER THAN A DOG; This spontaneous report received from a patient via a company representative 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. 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 patient experienced sicker than a dog. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sicker than a dog was not reported. This report was non-serious.  This case, involving the same patient is linked to 20221232897 and 20221232989.
Shot was inserted into right arm just slightly below the shoulder and I still have long lasting pain in my arm that comes and goes.
Possible cellulitis.  Red area from injection site into the bicep with some fluid.  Patient went to acute care and was given an antibiotic - doxycycline.  Injection was given 10/30/2023.  Reaction occurred 11/4/2023.  Patient went to acute care 11/4/2023 and started on antibiotic.  11/10/23 patient said symptoms are resolving.  She said it is still a little tender to touch.
Within seconds of injection, patient stated that she couldn't see, her eyes rolled back and her upper body began making a jerking motion then she slumped over. I was able to arouse her after approximately 30-60 seconds. She then began crying and stated that she had a bad headache. She was lethargic for roughly 20 minutes.
Fever (up to 101.4), full body aches, strong headache particularly at base of neck in back. Lymph nodes also swollen.. All symptoms lasted about 24 hours, then resided on their own with no intervention. Mild headache persisted for another 12 hours.
Child was given PENTACEL and ACTHIB on the same day. She received a double dose of Hib.
Migraine, Dizziness,  Nausea, Vomiting, Low Grade Fever
No additional AE reported; RN calling to report administration of expired vaccine to patient. Caller reports that MMR II lot expired on 8/26/22 and was inadvertently administered today 10/10/22. No additional AEs, no PQCs reported.; This spontaneous report has been received from a nurse and refers to a 4-year-old female patient. The patient's medical history, concurrent, previous drug allergies or reactions and concomitant therapies were not reported.  On an 10-OCT-2022, the patient was vaccinated with a expired vaccine of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (Albumin status of rHA (recombinant human albumin)) (M-M-R II) subcutaneous injection, 0.5 milligram (ml) once, lot number T028935, expiration date reported as 26-AUG-2022, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). No additional adverse event reported.
5 days following  the vaccination,  Patient suffered an ischemic stroke.  It was initially thought perhaps a UTI, due to the signs (confusion, vomiting, headache).  But the urine sample came back negative so she was taken to the ER by ambulance, where CT-scans and 2 MRI's were done, confirming the stroke (multiple strokes in the brain, but very small) and no bleeding.  After 5 days in the hospital, she spent 3 weeks in a rehab and is now back at her Assisted Living facility.
Information has been received from a registered nurse concerning a 28 year old male who was vaccinated with varicella vaccine on 03/02/2001 and on 04/10/2001. There was no illness at the time of vaccination. Subsequently on 05/10/2001 the pt experienced lack of response with a negative titer. The varicella zoster IGG was 1.01 negative. The pt had no adverse effects from the vaccine. Additional info is not expected.
Very large, raised, and painful at injection site and beyond. Patient made an appointment with primary doctor for him to look at it.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Information on concurrent condition, medical history or concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L029617 and expiry date 19-MAY-2017 (dose and route not reported). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Details of temperature excursion: Temperature: 48 F. Time frame: Undetermined, excursion occurred over the course of several days in February cumulative time frame was not provided. Previous excursion: No. Data logger involved: Yes. This is one of the two reports received from the same reporter. Additional information has been requested.
Patient developed a rash (no bumps) at the injection site the morning following the vaccination (Thursday).  Her arm also became inflamed, hard and hot.  Patient went to an urgent care facility on Friday (01/31/2020)..  She was prescribed doxycycline 100 mg (1 bid x 10 d) with a diagnosis of bacterial cellulitis.  She developed vomiting, diarrhea and nausea on Sunday (02/02/2020).  Thinking that the GI symptoms were due to the antibiotic, she stopped taking it after three doses.  It has been more that 24 hours since her last dose of doxycycline, yet the GI symptoms are still present.  She also reported some insomnia since the vaccination.  She also received an M-M-R II vaccination in the opposite arm at the same time, but there are no problems at that site.
Narrative: Per PCP note, upon discharge from hospital, 1/20/22: s/p COVID booster- then spent 8 days in the hospital after having terrible hives 6 days after getting the booster-he had severe n/v/d and hives and swelling Was in the ER at Facility for likely side effects to the COVID booster Moderna with n/v/d and severe swelling and hives. Was hospitallized for 8 days and was on 100 mg of Prednisone after being on Solumedrol. Still on Zyrtec 40  mg daily and Hydroxyzine 75 mg qhs and Famotidine 40 mg qhs. Seeing the private immunologist today, and saw over 12 specialists while hospitalized. Still having side effects from the steroids even though he completed them 2 days ago. Assessment/Plan: 1. S/P hospitalization for 8 days secondary to COVID booster reaction with hives and swelling. Seeing private immunologist.
Erythema, pain, swelling in (L) left deltoid and surrounding injection site. Treated with MOTRIN, BENADRYL, compresses, and KEFLEX due to being a diabetic.