chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received Pediarix #1; HIB #1 and Prevnar #1 on 3-20-07. Mother called on 3-21-07 to report hives. Called on 3-22-07 am to report hives intensified 3-21-07 pm but no other s/s of distress. On 3/22/07 no further outbreak
Large, blotchy rash appeared on left upper arm, near injection site of first Moderna COVID19 vaccine injection. Rash is warm to the touch. Rash is a few red blotches, a little larger than a deck of cards.
Itching, swelling, hot to touch at the site of the vaccination needle, arm sore - this is 8 days after the vaccinaton. Initial shot had arm pain the next 12-24 hours, then no symptoms. This new swelling and itching started this morning.
Patient vaccinated x2 (Moderna)  Patient tested COVID positive on 03/12/2022 and was then admitted to hospital
Extreme tiredness; This is a spontaneous report from a non-contactable consumer (patient).  A 66-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 13:30 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. There was no other vaccine in four weeks. The patient did not get COVID prior vaccination and COVID was not tested post vaccination. The patient experienced extreme tiredness on 21Jan2021.  No treatment was received. The outcome of the event was resolving.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
exposed with Covid-19 and she mentioned that she only got mild symptoms; exposed with Covid-19 and she mentioned that she only got mild symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "exposed with Covid-19 and she mentioned that she only got mild symptoms".  The lot number for bnt162b2 was not provided and will be requested during follow up.
I woke up in the morning and couldn't hear out of my right ear.  There is also a buzzing sound.
After first vaccine administered on April 30, 2021, patient developed severe headaches, photophobia, stiff neck, fever and chills that lasted 3 days.    Second vaccine was administered 3 weeks later on May 21, 2021, fever, chills, rigors, photophobia, stiff neck, severe headache continued for 2 weeks.  Patient went to an urgent care center and requested COVID rapid and PCR tests.   During the visit, a flu test and Lyme Disease test were done.   Tests were negative.    Patient continued to be symptomatic and sought medical care at medical center on June 8, 2021.   Patient received care in the ER and was admitted with a r/o diagnosis of meningitis.  Empirical meningitis protocol was started.   Spinal tap, blood cultures, urine cultures, tic borne infections were all negative.  Patient improved with prednisone therapy.  Patient discharged from hospital on June 11, 2021.  Negative tic and bacterial tests and rheumatoid panel were discussed during the post discharge visit on June 21, 2021.   It appears that the patient exhibited a severe adverse event reaction to the Pfizer Covid second vaccine dose.
Diarrhea; Lack of appetite; Nausea; Fatigue / Tired; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DECREASED APPETITE (Lack of appetite), NAUSEA (Nausea), FATIGUE (Fatigue / Tired) and VOMITING (Vomiting) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included APIXABAN (ELIQUIS) and VITAMIN D NOS for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), DECREASED APPETITE (Lack of appetite), NAUSEA (Nausea), FATIGUE (Fatigue / Tired) and VOMITING (Vomiting). At the time of the report, DIARRHOEA (Diarrhea), DECREASED APPETITE (Lack of appetite), NAUSEA (Nausea), FATIGUE (Fatigue / Tired) and VOMITING (Vomiting) outcome was unknown.            No concomitant medications were reported.
2 days after shot I felt unable to get deep breaths, slight pressure in chest and feeling of shortness of breath. 3rd day cough developed, and continued for 6 days, now is improved but still slight cough and not quite normal
Covid after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid after first dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid after first dose). At the time of the report, COVID-19 (Covid after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment history was not reported. The concomitant medication was not reported.
Erythema, some minimal swelling on day #1 after vaccine, enlarging in area by day #2. No tenderness, fever.
Information has been received from an NP concerning a 44 year old female pt with no known allergies and no significant past medical history who on 8/21/01 was vaccinated with a dose of MMRII (lot 638599/0598L). Concomitant therapy included calcium (unspecified) and multivitamins (unspecified). On 8/26/01, between 04:00 and 06:00, the pt developed a rash characterized by welts and hives from the neck down. It was noted that there were no welts on her face. The pt took Benadryl and reported that the welts went away. During the nights of 9/3/01 and 9/4/01, the rash appeared again. Once again, the pt took Benadryl and the rash remitted. It was noted that the pt was experiencing fewer patches with each reaction and that the rash was decreasing in severity each time it appeared and that the welts were getting smaller. The pt reported that she had changed nothing in her habits. Unspecified medical attention was sought. No further information was available. Additional information has been requested.
approx 24 hrs postt vaccine, patient experienced flu like symptoms and warm/sweaty feeling
Patient received expired vaccine. Expired 3/26, received 3/28. No adverse events. Patient opted to not receive revaccination.
Patient admitted to hospital on 12/08/2021 with symptoms of COVID: cough, fever, shortness of breath with exertion. Temp up to 101.5  02SAT 96% on Room Air Has been generally weak, BP 87/51, BANDS of 14%, Lactic acid level of 2.2 Chest xray shows bibasilar infiltrates RAPID COVID test is positive  Placed on supplemental oxygen 2 L nasal cannula
Patient received vaccine in AM, had seizure in PM at work with typical post-ictal picture.  Has epilepsy but no seizure since 2014. Also has history EtOH misuse but history not consistent with withdrawal.  Patient had some waxing and waning altered mental status, worsening slowly over next 2-3 days. Presented to ER with AMS. Initially thought to be EtOH withdrawal, but due to atypical clinical appearance, LP performed and HSV encephalopathy diagnosed.
Approximately one week after receiving my first shot I woke up with vertigo.  I have never had a bought of vertigo in my life.  The dizziness and spinning room sensation has been happening for about 8 hours now.
Patient reports she developed a rash, itching and headache that occurred the same day as the immunization. Patient contacted prescribers office to report symptoms and the office requested the vaccine information (lot number, expiration date) which was faxed to them same day.
Approximately 3 minutes after receiving the first dose of the Pfizer Covid 19 vaccine, the patient fainted. Symptoms included sweating, shaking, ringing ears and blurred vision. Patient also stated he felt as if he was tired all of a sudden and "fell asleep."
Received flu shot very high in my arm, told the pharmacist that the injection hurt unusually and pinched a lot. In days to follow I started to experience a great deal of pain and started to lose range of motion in my arm. Currently I am still experiencing a great deal of pain and have lost range of motion, I keep my arm to my side throughout the day and limit movement. I have seen an orthopedic specialist and am scheduled for MRI.
ACUTE NON ST ELEVATION MI 1/29/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE RESPIRATORY FAILURE 2/4/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/22/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/9/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/24/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE CARDIOGENIC SHOCK 12/29/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE NON ST ELEVATION MI 1/29/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED ACUTE RESPIRATORY FAILURE 2/4/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/22/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/9/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/24/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED CARDIOGENIC SHOCK 12/29/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED ACUTE NON ST ELEVATION MI 1/29/2023 CARDIOMYOPATHY, UNSPECIFIED ACUTE RESPIRATORY FAILURE 2/4/2023 CARDIOMYOPATHY, UNSPECIFIED ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/22/2022 CARDIOMYOPATHY, UNSPECIFIED  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/9/2022 CARDIOMYOPATHY, UNSPECIFIED RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/24/2022 CARDIOMYOPATHY, UNSPECIFIED CARDIOGENIC SHOCK 12/29/2022 CARDIOMYOPATHY, UNSPECIFIED ACUTE NON ST ELEVATION MI 1/29/2023 ACUTE EXACERBATION OF COPD ACUTE RESPIRATORY FAILURE 2/4/2023 ACUTE EXACERBATION OF COPD ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/22/2022 ACUTE EXACERBATION OF COPD CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/9/2022 ACUTE EXACERBATION OF COPD RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/24/2022 ACUTE EXACERBATION OF COPD CARDIOGENIC SHOCK 12/29/2022 ACUTE EXACERBATION OF COPD  ACUTE NON ST ELEVATION MI 1/29/2023 CARDIOGENIC SHOCK ACUTE RESPIRATORY FAILURE 2/4/2023 CARDIOGENIC SHOCK ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/22/2022 CARDIOGENIC SHOCK CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/9/2022 CARDIOGENIC SHOCK RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/24/2022 CARDIOGENIC SHOCK CARDIOGENIC SHOCK 12/29/2022 CARDIOGENIC SHOCK ACUTE NON ST ELEVATION MI 1/29/2023 PNEUMONIA ACUTE RESPIRATORY FAILURE 2/4/2023 PNEUMONIA ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/22/2022 PNEUMONIA  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/9/2022 PNEUMONIA RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/24/2022 PNEUMONIA CARDIOGENIC SHOCK 12/29/2022 PNEUMONIA
got their 1st Covid vaccine and now has Covid; got their 1st Covid vaccine and now has Covid; This is a spontaneous report from a Pfizer sponsored program Pfizer. A contactable pharmacist reported a male patient (another pharmacist) of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on unknown date. Medical history and concomitant medication were not reported. The patient got the first dose of COVID vaccine and now had COVID. Action taken for BNT162B2 was not applicable and outcome of the event was unknown.  Information on lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Gastrointestinal: upper left quadrant discomfort, abdominal distention, and abnormal endometrial presence.
Body aches and low fever on the next day of vaccination, followed by delayed skin reaction. Hive like rashes on abdomen, chest neck, back and armpits. Itchy but not painful. Still getting new bumps 3 weeks after.
Information has been received from a physician concerning a 25 year old male who was vaccinated with a dose of Gardasil because he was tested positive for HPV.  It was unknown whether medical attention was sought.  Patient's outcome was unknown.  No product quality compliant was involved.  Additional information has been requested.
Pt stated arm (L) was red, hot to the touch, swollen with a large knot at injection site. Pt stated it was on back part of arm where Pneumococcal PPV23 was given. Pt stated she has had fever and severe pain. Her white blood count was elevated - had red streak into armpit with swollen lymphnode - did not see pt only spoke on phone.
pt received the vaccine and was sat waiting  for the required 15 minutes after the shot., then he got up proceeding toward the pharmacy before the 15 minutes was up.   Fell forward and hit his head on the wall and landed on the ground.  an ambulance was called to scene. but pt refused the be taken.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Oct2023 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic obstructive pulmonary disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 4 (Booster), Single, Manufacturer unknown), for COVID-19 Immunization, reaction(s): "Covid-19"; Covid-19 vaccine (Dose 3 (Booster), Single, Manufacturer unknown), for COVID-19 Immunization, reaction(s): "Covid-19"; Covid-19 vaccine (Dose 2, Single, Manufacturer unknown), for COVID-19 Immunization, reaction(s): "Covid-19"; Covid-19 vaccine (Dose 1, Single, Manufacturer unknown), for COVID-19 Immunization, reaction(s): "Covid-19". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid in Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
headache.  Pt reports woke with headache behind R eye at midnight, has had simmialr headaches in the past which improved with IV fluids and antiemetics. 35 yo F w/ no known chronic medical conditions, presents w/ R-sided retroorbital HA + photophobia. Got the COVID vaccine yesterday morning; started to develop a right-sided, retroorbital, throbbing HA over the course of the day. +photophobia and nausea. Similar to prior "migraines;" the last one she had was more than 1 year ago. No visual changes. No fevers/chills, neck pain, rash, vomiting. No recent trauma.
Anxiety, unusual taste in mouth.  Observed 30minutes.  No worsening of condition. B/P 150/84@10:10  which is normal for patient (per patient). Disposition:  Stable
Child with multiple food allergies. Pain, redness. Received vaccine Mon 5/21/12, next evening about 30 hours later developed redness, itching & swelling at site of Varicella & DTaP vaccination. No fever, improved with BENADRYL.
Severe left shoulder pain started about 6 hours after the injections were given. Patient took over the counter pain medication for the pain.
This spontaneous report was received from a nurse practitioner and refers to a male patient of unknown age. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 30-SEP-2015, the patient was inadvertently vaccinated with improperly stored VARIVAX (Merck) injection (lot# K010440, expiration date 22-JUL-2016, dose, site and route of administration were not reported) instead of an intended dose of ZOSTAVAX. The nurse saw "varicella virus" on the VARIVAX (Merck) label and assumed that it was indicated for shingles vaccination. No adverse effect was reported. Additional information has been requested.
Pain and aching; Redness; Swelling; This spontaneous case was received on 27-Oct-2020 from other non-health professional (consumer) via Agency (reference number: SEQW20-04372) and concerned a female patient of unreported age.    The patient's medical history and concomitant medications were not reported.     On an unknown date, the patient was vaccinated with influenza virus vaccines polyvalent (brand not specified, dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.    On an unknown date, an unknown amount of time after receiving influenza virus vaccines polyvalent, the patient experienced some pain, redness, swelling and aching. The patient stated the reactions were normal and thought that was expected.   On an unknown date, a day or two after the injection, the reactions disappeared and the patient recovered from the events.   The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  Case updated on 26-Nov-2020: Correction made to information received on 27-Oct-2020: Suspect product recoded from 'INN Seasonal' to 'INN Flu Vaccine Seasonal'. No changes in narrative.   Company comment:The patient developed pain, erythema and swelling on an unknown date after vaccination with the suspect product, influenza virus vaccines polyvalent. Although onset date was not provided, narrative suggested plausible temporal relationship. No information regarding concomitant medications and medical history was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed pain, erythema and swelling on an unknown date after vaccination with the suspect product, influenza virus vaccines polyvalent. Although onset date was not provided, narrative suggested plausible temporal relationship. No information regarding concomitant medications and medical history was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
(See attached summary:) Hair loss, fatigue, muscle and joint pains, headaches, fever and intermittent diarrhea after receiving anthrax injections. Left arm: redness, blister and soreness at site that lasted 3-4 days. Took no medication. Felt tired, "all vaccines make me feel tired after taking them". Started having hair loss at the top of her head at 2 weeks after shot. Later had smallpox vax on 02/08/2003 and Anthrax #2 on 02/18/2003, with aggravation of above symptoms plus additional problems.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 24-JUN-2014 the patient ws vaccinated with properly stored, expired dose of ZOSTAVAX 19400 PFU) (lot # J010447,expiry date: 22-APR-2014) (subcutaneous, dose unknown). Pertinent medical history and concomitant medications were not reported. No adverse events were reported. The outcome of the events was unknown. No further information was provided. Additional information has been requested.
This spontaneous report as received from a register nurse refers to a 6 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 28-FEB-2014, the patient was vaccinated with dose 3 of ROTATEQ, lot #J007283; expiration date: 27-SEP-2014 (dose and strength were not reported. Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reported. Additional information has been requested.
She had a hard time urinating; She was awake all night last night; This spontaneous case was reported by a consumer and describes the occurrence of URINARY RETENTION (She had a hard time urinating) in a 73-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 23-Oct-2023, the patient experienced URINARY RETENTION (She had a hard time urinating) (seriousness criterion medically significant) and INSOMNIA (She was awake all night last night). At the time of the report, URINARY RETENTION (She had a hard time urinating) and INSOMNIA (She was awake all night last night) had not resolved.            Concomitant and treatment medications were not reported.  The patient's previous vaccination details were as follows: 1st dose - 26Feb2021 lot number 006M20A, 2nd dose - 28Mar2021 lot number - 028A21A, 3rd dose - 23Nov2021 lot number 031H21A, 4th dose - 16May2022 lot number - 004M21A, 5th dose - 07Nov2022 lot number - 062F22A.  On 23-Oct-2023, the patient was awake all the night. The patient was unable to urinate.  Company Comment This spontaneous case concerns a 73-year-old female patient with no medical history reported who experienced the unexpected seriousness criterion medically significant event of urinary retention and the unexpected event of insomnia the same day after a dose of mRNA-1273.815 vaccine. At the time of the report, the events had not resolved Concomitant medication nor Treatment details were reported. The benefit-risk relationship of mRNA-1273.815 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-747049 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747049:Spikevax case
pt recvd vax 16DEC93 & w/in 5 mins following vax pt exp itching; subsequently devel localized soft tissue swelling, heat & erythema;