chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lt forearmarea red swollen and sore 10/17/03.  Worse on 10/18/03 had to go to ER given antibiotic injection and rx for anitbiotics for cellulitis, benedryl no reaction at injection site.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No concomitant medications, medical history, drug reactions or allergies were reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (dose and route of administration were not reported, lot # M041079 with expiration date of 06-OCT-2018 and lot reported as M00996 with the expiration date of 07-JAN-2018) for prophylaxis. The vaccines were stored at temperature of 11.7 Fahrenheit degrees for 63 hours. Previous temperature excursion was also reported (storage at temperature of 6 to 14 Fahrenheit degrees for 13 hours). Temperature excursion was detected by digital data logger. No adverse effects were reported. Lot number M00996 is an invalid lot number for varicella virus vaccine live (oka/merck).  This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA009126:
INSTANT PAIN DOWN ARM TO WRIST. WITHIN HOUR S UPPER BODY PAIN , SWELLING LEFT UPPER ARM. UPPER BODY PAIN ARMS AND BACK DAY 2 PAIN IN MUSCLE AND BONES , MUSSEL FITUGE DAY 3 PAIN BAD UPPER BODY MUSCLE SHACKING FITUGE NITE SWEETS PELVIC PAIN  NO FEVER MUSCLE AND BONE ARM BACK PAIN  2 WEEKS UNDER ARE SEEN SWELL TENDER TO TOUCH .  CALLED AFTER DAY 4 TO REPORT . HOT BATH, ARITHUS TYLENOL. REST UN ABLE TO LIFT ARM  SEVER PAIN
Starting on day 6 post vaccine, I started experiencing much fatigue which grew worse until day 11 post vaccine. The fatigue was debilitating in that I had a hard time getting out of bed and needed 10-12 hrs. Day to function at a minimum level such as cooking and going to work. Today is day 12 post vaccine and I am still experiencing this effect. I have contacted my doctor who advised me to go ahead and fill out.
The doctor said it was an acute COPD flare up. I was having a hard time coughing and breathing. The symptoms are still ongoing and started about the 1st of may.  I went to the doctor, they did a chest xray and gave me prednisone, nebulizer. I still have lingering cough that was worse before covid and still don't have my sense of taste, I can't taste anything that's spicy everything else has come back except that one.   I had COVID Nov 29, 2020
I had dizziness; I developed a superficial blood clot on my right calf; maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of THROMBOSIS (I developed a superficial blood clot on my right calf) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided.  Concomitant products included LORATADINE, NORTRIPTYLINE, PROBIOTICS NOS and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 01-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). On 14-Jun-2021, the patient experienced THROMBOSIS (I developed a superficial blood clot on my right calf) (seriousness criterion medically significant). On an unknown date, the patient experienced DIZZINESS (I had dizziness). The patient was treated with APIXABAN (ELIQUIS) at an unspecified dose and frequency. At the time of the report, THROMBOSIS (I developed a superficial blood clot on my right calf) had resolved and DIZZINESS (I had dizziness) and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This is a spontaneous pregnancy case concerning a 39-year-old female patient with no reported medical history, who experienced the serious (medically significant) unexpected event thrombosis, 42 days after receiving the second dose of mRNA-1273.  Patient reports experiencing a superficial blood clot on her right calf. Further information has been requested. Maternal exposure during pregnancy was also captured as an event. Pregnancy remains as confounder for the event thrombosis. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous pregnancy case concerning a 39-year-old female patient with no reported medical history, who experienced the serious (medically significant) unexpected event thrombosis, 42 days after receiving the second dose of mRNA-1273.  Patient reports experiencing a superficial blood clot on her right calf. Further information has been requested. Maternal exposure during pregnancy was also captured as an event. Pregnancy remains as confounder for the event thrombosis. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Chest pain, left arm tingling, rash, dry mouth, diaphoretic, flushed-
Rash started on 7/17/15, 10 days after vaccine given-rash got worse, spread from trunk to face and took to ER on 7/18/15 when welts appeared-T 98.9-gave Ibuprofen Q 6 h prn.
POSSIBLE CHILD UNDERAGED. DOB REPORTED INCORRECT ON CONSENT BUT OTHER RECORDS INDICATE ACTUAL DOB.
Initially she started with tremors while asleep, progressed to nightime paralysis, sleep disorder symptoms, cataplexy, etc. Sleep studies and doctor investigations eventually led to diagnosis of cataplexy and narcolepsy, non-genetic, caused by damage.
Swollen glands left side of neck. Soreness in joint of left shoulder ,elbow ,hand .Tingling in hand .Soreness down left side and the hip area .
Pt rec'd 1st & 2nd dose vax 20DEC89 & 19JAN90 resp; On 7MAY90 pt exp loss of control of rt side of face, numbness of rt side of tongue; sx switched to lt side of face; exp loss of feeling & drooping of lt side; Dx Lyme Disease;
Dizziness, headache and vomiting. Onset <24 hours after administration of Adacel (Tdap)
Information has been received from a nurse on 11-FEB-2015 referring to a patient of unknown age. On 27-JAN-2015 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX injection, 0.5 ml, subcutaneous (lot# was not reported) which underwent a temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Medication Administration Error: Patient is only 16 years old, so not eligible for a booster.  Patient and mother of patient approached RN - vaccinator. RN states that she verified patients' name and date of birth but stated she had not verified age. RN states miscommunication with parent, that the mother was very insistent that her son get booster since he is an athlete. Patient waited mandatory 15 minutes and departed without issue
Breakthrough case admission after three vaccines Moderna 2/9/21 Lot# 013M20A;  Moderna 3/9/21 Lot# 010A21A;  Moderna 10/28/21 Lot# 005C21A
continuing pain in left arm muscle between shoulder and elbow; less pain when standing; pain keeps patient awake at night when lying down
By September, 2021, patient noticed moderate tinnitus. Originally she thought it would resolve but by March 4, 2022, Patient saw Dr's partner. Was treated for sinus infection with Doxycycline x 7 days. Tinnitus was worse at that time and she was concerned about taking medication, but she did. Returned to Dr again on March 31, 2022 for worsening symptoms, headache, sore throat, cough, neck pain, tinnitus, congesion, was treated with Prednisone, Baclofen, Flonase. April 12, 2023 returned for worsening cough, nasal congesion, tinnitus. Was given Levaquin, Flonase, Zyrtec, Astelin. Was referred to ENT.  On May 9, saw audiologist and ENT, recommended hearing aides and surgery for nasal septal defect, that that might help her tinnitus. Had surgery on  October 12, 2022.  No complications from surgery but no improvement of tinnitus.  September she returned to doctor with tennis elbow and hair loss, but doctor told her it was from  surgery. November 20, 2022 went to ER for respiratory symptoms, coughing again and was placed on antibiotic and inhaler. Tinninitus continues and she was told that she will have to learn to live with it.
intense pain; migraine became more severe; affects vision/she can't read printed writing like a book unless she takes medication; nausea worsens; head hurts so bad even in the dark; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (intense pain), MIGRAINE (migraine became more severe), VISUAL IMPAIRMENT (affects vision/she can't read printed writing like a book unless she takes medication), NAUSEA (nausea worsens) and HEADACHE (head hurts so bad even in the dark) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 004C21A) for COVID-19 vaccination.     Concurrent medical conditions included Insulin-dependent diabetes mellitus. Concomitant products included INSULIN for Insulin-dependent diabetes mellitus, ONDANSETRON (ZOFRAN [ONDANSETRON]), HYDROCODONE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2021, the patient experienced PAIN (intense pain), MIGRAINE (migraine became more severe), VISUAL IMPAIRMENT (affects vision/she can't read printed writing like a book unless she takes medication), NAUSEA (nausea worsens) and HEADACHE (head hurts so bad even in the dark). The patient was treated with UBROGEPANT (UBRELVY) for Migraine, at an unspecified dose and frequency and CLONAZEPAM for Nausea, at an unspecified dose and frequency. At the time of the report, PAIN (intense pain), MIGRAINE (migraine became more severe), VISUAL IMPAIRMENT (affects vision/she can't read printed writing like a book unless she takes medication), NAUSEA (nausea worsens) and HEADACHE (head hurts so bad even in the dark) outcome was unknown.            Patient reported that, she had been taking a double dose of Zofran and when that doesn't work she takes clonazepam for her nausea. She also reports that, she doesn't eat until late sometimes because the migraines and that it affects her insulin dependent diabetes. She said that, she has breaks for 3 or 4 days without headache. She said, she has to keep the left eye closed and right eye open because her head hurts so bad even in the dark. She reports getting 24 Botox shots in the head last month by her neurologist.   This case was linked to MOD-2021-288701 (Patient Link).
organs shut down after vaccine; A spontaneous report was received from a female consumer via social media regarding her father, unknown age, who was administered Moderna Covid-19 Vaccine and have experienced multiple organ failure.  The patient's medical history was not provided. His concomitants were not provided.   On an unspecified date, prior to onset of symptoms, the patient received their a planned doses of mRNA-1273 (Lot Number: unknown) unknown route of administration. It is not known whether patient received first dose or 2nd dose of vaccine.  On an unknown date the patient experienced shut down of multiple organs. It was noted that the doctors said, there was no concrete proof that its due to vaccine. But according to her, the patient was fine till he had the vaccine. Treatment details were not provided. Doctors talked about do not resuscitate orders with her.  Action taken with the vaccine is unknown.   The outcome of the event multiple organ failure is unknown at the time of report.; Reporter's Comments: This case concerns a male patient, who experienced a serious unexpected event of Multiorgan failure after receiving mRNA- 1273 (Lot# Unknown). Very limited information regarding this event has been provided at this time. Due to lack of contact details, no follow-up information is expected.
This spontaneous report as received from a physician who saw on the internet (using Google) refers to a female patient (school girl) of unknown age. A couple years ago on an unknown date the patient was vaccinated with GARDASIL (dose, route, lot# and expiration date unknown) and then developed Tourette's Syndrome. The outcome of the event was unknown. The physician had no further information about this school girl or the name of the website where he saw this report. This is one of several reports received from the same source. Additional information has been requested.
nausea; headache; arm sore; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore), FATIGUE (fatigue), NAUSEA (nausea) and HEADACHE (headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included LOSARTAN and LEVOTHYROXINE for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm sore) and FATIGUE (fatigue). On 26-Feb-2021, the patient experienced NAUSEA (nausea) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-Feb-2021, PAIN IN EXTREMITY (arm sore) and FATIGUE (fatigue) had resolved. At the time of the report, NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient recieved fist dose of Pfizer Bivalent on 09/10/2022 then scheduled and recived a 2nd dose of Pfizer Bivalent on 11/22/2022. No adverse events per patient to report
Sudden onset of dizziness followed by severe nausea. Fever developed in the evening treated with Tylenol. Nausea has persisted thru 10/13/2010 treated with medication but not resolved. Resulted in time missed at work.
loose bowels; aches; chills; fever; Nausea; fatigue; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 72-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: El9265) via unspecified route in left arm on 17Feb2021 at 12:15 at single dose for covid-19 immunization. The patient had allergy to penicillin. The patient historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El9267), via unspecified route on 27Jan2021 at 11:45 at single dose for covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included Claritin, vitamin d3, fish oil magnesium, zinc. The patient did not receive any other vaccines within four weeks prior to the vaccination but other medications in two weeks include Claritin, vitamin d3, fish oil magnesium, zinc. On 18Feb2021 at 03:00 patient experienced chills, fever, loose bowels, nausea, aches, fatigue. The patient did not receive any treatment for the events. The outcome of the events was recovered.
Rapidly Progressive leg left leg weakness starting day after vaccination and progressing to immobility of left leg, left quadriceps muscle atrophy - loss of 7cm circumference 5 inches above knee within a month, progressing to bilateral leg weakness, mri of c,t,l spine obtained and no obvious cause of neurogenic changes/atrophy, muscle biopsy completed and shows undefined myopathy with neurogenic changes, lab panel to rule out autoimmune myopathies- negative.  Determined differential diagnosis polymyositis vs dermatomyositis
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 2:19 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 2:19 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 27.18.  Concomitant products were not provided.  On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 PM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
PFIZER EN6139 lot on 5/19/2021, PFIZER EP7534 on 6/09/2021. Peyronie's/ Penile Thrombosis. Gradual bending of erect penis started soon after 2nd shot and gradually increased in bending. Now over 90deg bend making penetrative intercourse IMPOSSIBLE. Visual sightings causing stomach sickness in patient (self) and now ALL interest in any sex activity is destroyed. Two are impacted due to this, as patient is married. THIS DOES NOT RUN IN THE FAMILY and NO AGGRESSIVE SEX was responsible in any way (Patient is 56!).
not eating, refuses bottle, fussy but consolable. temp 97.9. tylenol  per mom prior to visit.
"I feel dizzy and my chest hurts" has asthma - no apparent breathing difficulties observed. No local reaction. Grfa is bringing inhaler. Used inhaler - feels better but leg hurts. Grfa called again - will pick up. Grfa picked up @ 11.55, gave inst. to call MD with further difficulties.
This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown gender and age. Information regarding their medical history, concurrent conditions and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # L045953, expiry date: 17-NOV-2017; lot # L045954, expiry date: 17-NOV-2017). Nurse reported that the vaccine underwent temperature excursion at 6.5 and 8 degree Fahrenheit (F) for 28 and 30 minutes, respectively. She reported that the vaccine underwent temperature excursion previously also, on unknown dates. The vaccine was exposed to 7F, 7.5F and 6.5F for 22 minutes, 23 minutes and 28 minutes, respectively. No adverse effects were reported. Additional information is not expected as the reporter did not wish further contact.
jellybean size" Knot in the IS left arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (jellybean size" Knot in the IS left arm) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Epilepsy.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced INJECTION SITE MASS (jellybean size" Knot in the IS left arm). At the time of the report, INJECTION SITE MASS (jellybean size" Knot in the IS left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.     Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up was received and there was no new information.
Vaccine given - 8-21-13. Symptoms 8-27-13 - high fever. Pale, weakness, blackouts, irregular heartbeat, fatigue - flu like.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 20-OCT-2014 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # J002641, expiration date 04-NOV-2016; dose frequency and route unspecified). No adverse effects were reported. The storage criteria was refrigerator (R). Celsius conversion of the lowest recorded temperature was 1 (Fahrenheit degree/Celsius). The total cumulative excursion time was 48 hours with the lowest recorded temperature 1 (Fahrenheit degree/Celsius) and the type of excursion (R/F) was R. This is one of several reports received from the same source. Additional information has been requested.