chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This progressed to nausea by about noon the day following the vaccine; Ate a light supper and felt ok except tired; Within 12 hours post vaccine hadbody aches; Then had to get up around 1 am due to abdominal pain epigastric and upper quadrant; dry heaving; vomiting small amount clear liquid; Patient was administered Booster dose 3, BNT162b2; Patient was administered Booster dose 3, BNT162b2; This is a spontaneous report from a contactable physician, the patient. A 63-year-old non-pregnant female patient received the third dose (BOOSTER DOSE) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the left arm on 01Oct2021 at 16:00(at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the left arm on 29Jan2021 at 09:00(at the age of 62-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 26Feb2021 at 08:00(at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient previously took influenza vaccine (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. On 02Oct2021 at 04:00, within 12 hours post vaccine, the patient had body aches and no fever. On 02Oct2021 at 12:00, the patient reported that this progressed to nausea by about noon the day following the vaccine, ate a light supper and felt ok except tired. On 03Oct2021 at 01:00, the patient had to get up due to abdominal pain epigastric and upper quadrant, severe nausea, dry heaving and vomiting small amount clear liquid, this lasted until about 10:30 on 03Oct at which pain subsided and nausea much better allowed her to eat a light breakfast. The patient reported that she was a gastroenterologist and she could attest that she never had nausea or vomiting. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with took some tums. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events within 12 hours post vaccine had body aches. This progressed to nausea by about noon the day following the vaccine. Ate a light supper and felt ok except tired. The patient had to get up due to abdominal pain epigastric and r upper quadrant, severe nausea, dry heaving and vomiting small amount clear liquid were recovered on 03Oct2021 at 10:30.
Within 10 minutes, developed SOB and diaphoresis and malaise Monitored patient for 30 minutes. Took vital signs.
Rash on shoulder chest arms and legs. Itchy everywhere. Sore muscles and fatigue
lethargic, nauseous, extremely cold, extreme swelling, redness, and pain  of right arm from elbow to shoulder,
Patient's arm was red and swollen at the site of vaccination. Patient also reported a fever of 103 degrees.
Child received lower dose than recommended for his age group. Patient is 6 years old, but received the Pfizer Covid vaccine for 6mth-5yo.
Pharmacy has my records for all vaccines.  I experienced hard heartbeats on and off for about a month after taking the dual COVID booster.
Client complains of normal vaccine side effects on 2/18 and 2/19 (chills, muscle aches, nausea, vomiting). Client reports extreme arm pain, redness, and swelling of arm.  Redness and swelling has now extended down past elbow of right arm.  Advised client to seek medical treatment by primary care physician.
FEVERS OF 106 DEGREES F; GI PROBLEMS; WEIGHT LOSS; TRANSIENT VISUAL DISTURBANCES; TINNITUS; MYALGIAS; This spontaneous report received from a physician concerned a female of unspecified age of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was reported to be healthy prior to receiving the vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, administered on 22-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. The physician reported that the patient was Medical mystery to them. It was reported that on an unspecified date the patient experienced fevers, myalgias, significant headache, difficulty hearing with tinnitis, fevers of 106 degrees F, transient visual disturbances, GI problems, and weight loss and has been hospitalized (dates unspecified), multiple times for unspecified days. The physician reported that they have done a million-dollar work-up on her, including 3 lumbar punctures which have come back negative. They have worked her up for AIDS (HIV test), ANA (Antinuclear antibody), sent out an encephalitis panel to clinic, and had checked viral panels which have all ended up negative. The patient had consistently been experiencing these symptoms. When she was put on 60 mg of prednisone, she improved, but the benefits go away once they start to taper her dosage. The patient had returned to the hospital. The Reporter said they are currently consulting ENT, and are suspecting something that was autoimmune in nature, but everything has been negative thus far. Laboratory data (dates unspecified) included: AIDS (NR: not provided) Negative, ANA (NR: not provided) Negative, Body temperature (NR: not provided) 106 F, Lumbar puncture (NR: not provided) Negative, and Viral test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from myalgias, fevers of 106 degrees f, GI problems, weight loss, transient visual disturbances, and tinnitus. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211121646-covid-19 vaccine ad26.cov2.s- fevers of 106 degrees f, GI problems, weight loss, transient visual disturbances. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20211121646 -covid-19 vaccine ad26.cov2.s- tinnitus, myalgia. This event(s) is labeled per RSI and is therefore considered potentially related.
Fever, lethargy, sinus congestion and drainage, sore throat, large red area on arm where shot administered?.lasted 4+ days
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Nausea-Mild
Rash/Hives all over my whole entire body. Extreme itchiness. Legs look more like my skin was burned - large patches of red and purple. It has now been over a month and it is still persisting.
This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received HAVRIX. Co-suspect products included BOOSTRIX, PEDIARIX, KINRIX, INFANRIX, ROTARIX and ENGERIX B. On an unknown date, the patient received HAVRIX at an unknown dose, BOOSTRIX at an unknown dose, PEDIARIX at an unknown dose, KINRIX at an unknown dose, INFANRIX at an unknown dose, ROTARIX at an unknown dose and ENGERIX B at an unknown dose. On an unknown date, an unknown time after receiving HAVRIX, BOOSTRIX, PEDIARIX, KINRIX, INFANRIX, ROTARIX and ENGERIX B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: Several of GSK vaccines were exposed to temperatures below 32F and some patients were administered these vaccines. No details available.
This spontaneous report was received from a physician via company representative refers to a 13 year old male patient. The patient's medical history and concurrent conditions were not reported. On an unspecified dates the patient was vaccinated with first and second dose of GARDASIL (intramuscular, dose, anatomical location and lot numbers was not reported). Concomitant medications were unspecified by reporter. On an unknown date, following administration of first and second doses, the patient developed redness and swelling around the injection site. The reporting physician had continued to administer the third dose in "quarter increments'. The initial "quarter increment" had been administered on an unknown date. The outcome of the events was reported as recovered/resolved. The causal relationship between the events and GARDASIL was not reported. Additional informaton has been requested.
Received a 0.25ml dose; A spontaneous report was received from a consumer who was also a 59-years old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced received a 0.25 milliliter (mL) dose.  The patient's medical history, as provided by the reporter, included diabetes. Concomitant medications reported included unspecified diabetes medication.  On 22 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient noticed that he received a 0.25 mL dose rather than the full 0.5 mL dose. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, received a 0.25ml dose, was considered resolved on 22 Jan 2021.; Reporter's Comments: This case concerns a 59-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age.
excruciating pain/vaccine symptoms hurt 20 times more; cannot sleep or do anything; cannot lift a piece of paper; completely disabled right now and cannot go to work; vaccine rash (large patch); cannot go to work/ can not do anything; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (excruciating pain/vaccine symptoms hurt 20 times more), INSOMNIA (cannot sleep or do anything), VACCINATION SITE MOVEMENT IMPAIRMENT (cannot lift a piece of paper), MALAISE (completely disabled right now and cannot go to work), VACCINATION SITE RASH (vaccine rash (large patch)) and IMPAIRED WORK ABILITY (cannot go to work/ can not do anything) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 028A21A) for COVID-19 vaccination.     The patient's past medical history included Arthritis and Knee surgery NOS.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (excruciating pain/vaccine symptoms hurt 20 times more) (seriousness criterion disability), INSOMNIA (cannot sleep or do anything) (seriousness criterion disability), VACCINATION SITE MOVEMENT IMPAIRMENT (cannot lift a piece of paper) (seriousness criterion disability), MALAISE (completely disabled right now and cannot go to work) (seriousness criterion disability), VACCINATION SITE RASH (vaccine rash (large patch)) (seriousness criterion disability) and IMPAIRED WORK ABILITY (cannot go to work/ can not do anything) (seriousness criterion disability). At the time of the report, PAIN (excruciating pain/vaccine symptoms hurt 20 times more), INSOMNIA (cannot sleep or do anything), VACCINATION SITE MOVEMENT IMPAIRMENT (cannot lift a piece of paper), MALAISE (completely disabled right now and cannot go to work), VACCINATION SITE RASH (vaccine rash (large patch)) and IMPAIRED WORK ABILITY (cannot go to work/ can not do anything) outcome was unknown.            Concomitant product use was not provided.  Symptoms started 7 days after the shot and lasted 2.5-3 weeks.  Patient wanted to knowif could take paracetamol to treat symptoms. The vaccine symptoms hurt 20 times more.  Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to -MOD-2021-072900 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: TCR - reporter/patient name obtained.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. -MOD-2021-072900:
Deceased 11/12/2021; Hospitalized 11/11/2021; COVID-19 positive 11/10/2021; fully vaccinated  BRIEF OVERVIEW: Discharge Provider: DO Primary Care Physician at Discharge: MD Admission Date: 11/11/2021   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute UTI Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present COVID-19   HOSPITAL COURSE: Patient is a 88 y.o. female, with a PMH of atrial fibrillation, CHF, CKD stage 3, hypertension, asthma, depression, anxiety, chronic pain, hypothyroidism, mild cognitive impairment, who presented to the emergency department with ongoing nausea/vomiting and diarrhea. In the ED the patient was noted to be hypertensive with an elevated heart rate.  EKG confirmed AFib with RVR.  She was noted to be hypoxic and placed on 3 L. Laboratory evaluation revealed an elevated white blood cell count and a lactate of 5.6 which trended down to 5.1 following 1 L of normal saline.  Chest x-ray showed extensive multifocal pulmonary opacities.  CT of the abdomen and pelvis showed evidence of COVID-19 pneumonia with small to moderate pleural effusions and marked cardiomegaly.  She did test positive for COVID-19.  Urinalysis was suspicious for urinary tract infection.  Patient was given a total of 2 L of normal saline, Decadron Rocephin. She was admitted to the hospitalist service for further care. She has an out of hospital DNR on file.    Overnight her work of breathing increased as well as oxygen demand. She also became hyopthermic and hypotensive.   Due to decline overnight and wishes to be DNR patient's family was contacted and planned to be at bedside by morning however a RAP was called at 715am for hypotension. On evaluation the patient had no chest rise and was not breathing. Tele showed asystole. Pronunciation of death was completed at 0720 and family was informed (daughter and son-2 children. Her other son was not able to be reached) along with patients PCP. Death certification to be completed by admitting physician.
A mother reported that her son received Orimune, Acel-Imune vaccine, and MMR II vaccines on 10/9/98 at 5 years of age. Since that time, he has shown signs of autistic tendencies. She inquired about the mercury content of some of the vaccines. She reported that tests performed were inconclusive and urine tests for mercury were negative. Medical history provided that the child was born 5 weeks premature. The patient's experience was considered medically important (OMIC). The reporter declined additional information.
continuous sore arm, almost two weeks after the second pfizer vaccine shot. couldn't raise the arm, even for an empty dish plate, i can feel my arm is  shaking when i hold it.   similar situation happens after the first pfizer vaccine shot. about two weeks after the first shot, my arm had occasional sharp pain for about 3 days.   no rash no swollen on arm.
Diagnosed by primary care physician, Dr., on June 14, 2021 with shingles. Prescribed Valacyclovir, 1gm tablet by mouth three times daily for 7 days.  Currently have 7 patches of rash with clear blisters on right side of body, front and back above waistline.
Received 1st Moderna vaccine on Thursday afternoon.  On Friday night, patient noticed redness and swelling at the injection site in left arm.  On Saturday morning, noticed increased redness.  By Saturday night, swelling had also increased to a golf ball-sized mass.  Patient also began to experience itching in various spots on body (spot on wrist, multiple spots on legs, top of head), as well as pain in ears and joint pain.  On Sunday night, took Benadryl which helped relieve itching somewhat.  Informed the pharmacy that performed vaccination on Monday morning.
2 days after DTAP, arm red & swollen & warm deltoid area. No fever.
Information has been received from a medical assistant referring to a 3 year old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was unknown. On 09-NOV-2018 the patient received an improperly stored dose of PROQUAD (lot # R012417, expiry date: 28-OCT-2019; dose, frequency and route were not reported) for prophylaxis (product storage error), which was reconstituted with properly stored sterile diluent (STERILE DILUENT). No adverse effects were reported. There was no previous temperature excursion. It was also reported that temperature was from 15 fahrenheit to 46 fahrenheit for 8 hours and the data logger was involved.; Sender's Comments: US-009507513-1902USA007542: US-009507513-1902USA007540: US-009507513-1902USA007537: US-009507513-1902USA007541: US-009507513-1902USA007539: US-009507513-1902USA007538: US-009507513-1902USA007536: US-009507513-1901USA008772: US-009507513-1902USA007544: US-009507513-1902USA007545: US-009507513-1902USA007546: US-009507513-1902USA007547: US-009507513-1902USA007548: US-009507513-1902USA007549: US-009507513-1902USA007550.
Red, Itchy Eyes Tightness in chest Temp 101 Pulse Oximetry at ER 91%
This is a spontaneous report obtained from a contactable consumer who reported for her husband. A 58-year-old male patient received, on 19May2016, in the afternoon, the second dose of PREVNAR 13 0.5 ml, single dose, tetanus vaccine and hepatitis series vaccines. Relevant medical history included renal failure (the patient was in the last stages of renal failure and he was going to get a kidney transplant. The preliminary requirement to get a kidney transplant was to have hepatitis series, the tetanus and pneumococcal 13-val con vac). He did not have other issues. The patient received an unspecified concomitant medications. The patient received the first shot of PREVNAR 13 on 14Apr2016, at 0.5 ml, single dose. On 20May2016, at 04:30, in the morning, the patient experienced heaviness on his chest. The patient described it as "a stabbing pain" and it lasted for 5 minutes. Hospitalization was required. The patient was put on heart monitor and a whole series of blood work were performed. Chest x-ray with the isotopes ruled out any kind of blood "clots" in the lungs and they also ruled out a heart attack. The patient recovered from the events, on 20May2016.
The day of the vaccine, nothing signficant.  The next day when I woke up, I had a cough and fever of 101F.  That lasted about a week til 1/26/2021.  I took Tylenol and  ibuprofen.  On 1/21/2021 did a telehealth virtual visit and doctor called in RX for prednisone. Fever went away first  and cough lingered.   On 1/26/2021 all symptoms improved and went away.
pt  to ED on 4/24/22 with AMS, syncope, unresponsive; when pt regained consciousness he requested to allow natural death; DNR; pt passed away in the ED; post-mortum  testing done at Institute showed a positive COVID test
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Arm hot to the touch, recomended ibuprofen and to follow up with pcp if ibuprofen doesn't clear it up
Terrible deep cough; Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer. This is report 3 of 5. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: unknown) via an unspecified route of administration in arm left on 07Aug2021 as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were none. On an unspecified date, patient tested positive for COVID and experienced cough. Reporter also stated she was with person who was coughing their brains out but had a mask on, another person who wasn't wearing a mask, and the third per-son who only had one shot. All three tested positive for COVID and she was the only one who did-n't. She had a terrible deep cough. She was very contagious. Patient's husband had COVID and didn't know it but was cured. His symptoms resolved in 2 days but was shedding the virus appar-ently. She clarifies husband was not wearing a mask and was talking a mile a minute, he had just gotten over COVID that week and was fine. He had gone back to work and everything. Reporter confirms they all three people at the dinner with her tested positive for COVID. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Additional information provided updated test results. Information regarding PREVNAR was received from a healthcare professional regarding a 2-month-old female patient who experienced diarrhea. At 2 months of age, the patient received a dose on 06-Nov-2009. The patient also received a dose of Hepatitis B vaccine (manufacturer unknown) and a dose of PENTACEL (Aventis-Pasteur) on 06-Nov-2009. The patient experienced diarrhea on 07-Nov-2009. The patient recovered (2009). No additional information was available at the time of this report.
COVID-19 mild symptoms; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19 mild symptoms) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 030L20A and 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety and Regurgitation. Concomitant products included CLONAZEPAM (KLONOPIN) for Anxiety, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Regurgitation.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced COVID-19 (COVID-19 mild symptoms). At the time of the report, COVID-19 (COVID-19 mild symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received first booster dose on 29-Oct-2021.  No treatment medication were provided.  Company Comment : This spontaneous case concerns a 63-year old female patient with no relevant medical history reported, who experienced  a non-serious unexpected AESI of COVID-19 approximately 1 year 3  months after receiving the second dose and approximately 6 months after the booster dose of mRNA vaccine. There is no information about the symptoms, the test reports and treatment details provided.  Current pandemic is considered a risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-647508 (Patient Link).; Sender's Comments: This spontaneous case concerns a 63-year old female patient with no relevant medical history reported, who experienced  a non-serious unexpected AESI of COVID-19 approximately 1 year 3  months after receiving the second dose and approximately 6 months after the booster dose of mRNA vaccine. There is no information about the symptoms, the test reports and treatment details provided.  Current pandemic is considered a risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.