chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hard time being able to function without falling over.; falls on his face; Dizziness; This is a spontaneous report from a contactable consumer or other non hcp (patient fiancee). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date in Aug2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified in 2021, the patient experienced dizziness and hard time being able to function without falling over. Reporter and patient got the Pfizer Vaccine last week and reporter believed patient may be having some adverse side effects. He was having a dizziness and hard time being able to function without falling over. Reportedly, it was 6:00 in the morning in (withheld) which means it was only 7:00 in (withheld), reporter asked so what are we supposed to do he woke up at 06:00 in the morning central time and falls on his face. This was (withheld) pounds man reporter talking about. Reporter cannot just pick him up. Reporter asked gonna be a better solution then some helpdesk that was only open form 8 to 8. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
On 3/02/07 patient was diagnosed with chickenpox by doctor. At the visit, patient's sister was vaccinated for protection. On 3/22/07, patient was again diagnosed clinically with chickenpox. Viral culture was insufficient/ no result. Patient had been vaccinated as an infant for Varicella.
Information has been received on 24-JUL-2017 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration were not reported) subcutaneous on or about 10-JUL-2013 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 08-JUL-2016, the patient was treated by a  physician at a clinic for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
COVID; COVID; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID".  Clinical course: Reporter stated patient might have COVID despite being vaccinated. The patient's whole family got COVID right after (DEIDENTIFIED). Everybody got it. Causality was not reported  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information and the known product safety profile a causal relationship between the reported events, COVID 19, Drug Ineffective and BNT162B2 is considered possible.
Doses administered after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications and treatment information were not provided by reporter.  The Moderna vaccine BUD was 16-Jan-2022.  Reporter confirmed that 23 patients received shots after the 30-day use by date. Dose administered after 30-day Use By Date or after manufacturer date of expiry. Number of doses/vials: 23 doses. On 17-Dec-2021, the vial was initially stored in the refrigerator. The vial didn't undergo any temperature excursions.
Arm swollen and red 24 hours after shot.  Much larger, red, swollen, warm the next day.
Pfizer.  Flu like (headache, stomach nauseous) sore arm. Rash/shingles. Still have rash and sore head from rash
Terrible persistent high-pitched ringing in right ear perhaps both ears, but loudest in right ear.; Terrible persistent high-pitched ringing in right ear perhaps both ears but loudest in right ear.; Hard to sleep, concentrate; Feels very annoying but bearable other times feel like crawling out of skin; Hard to sleep, concentrate; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 08Apr2021 at 15:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, anxiety, depression, and occasionally experienced tinnitus, but it would come and go and not last for very long which was not ongoing. The patient had an allergy to sulfa. 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 COVID vaccine. Concomitant medications included clonazepam (MANUFACTURER UNKNOWN) and lamotrigine (MANUFACTURER UNKNOWN) both were taken for unknown indications from unknown dates (as long-term medications) and unknown if ongoing. Since an unknown date in Apr2021, not long after receiving the first vaccine, the patient was experiencing a terrible, persistent, high-pitched ringing in the right ear, perhaps it was both ears, but it was loudest in the right ear. It was hard to sleep, concentrate, etc. Sometimes it felt very annoying, but bearable, other times the patient felt like crawling out of the skin with it. It was with the patient when she woke up and goes to sleep. Every now and then, the patient felt it was much quieter, or that it had stopped, but then it would start right up again. The patient was supposed to get the second vaccine on 29Apr2021 but was not sure what to do. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events terrible persistent high-pitched ringing in right ear perhaps both ears but loudest in right ear, hard to sleep, concentrate and feels very annoying but bearable other times feel like crawling out of skin were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
RASH: RED, PAPULAR, DISTRIBUTED IN IRREGULARLY SHAPED PATCHES, WIDESPREAD, MILDLY PRURITIC, PATCHES BLANCHE WITH TOUCH, INJECTION SITE ON LEFT THIGH IS BRIGHT RED & FIRM TO TOUCH, NOT WARM TO TOUCH & NO STREAKING FROM SITE  TREATMENT: BENADRYL ALLERGY
Blotchy, red rash. Extreme anxiety and extreme hyperactivity, inability to concentrate, difficulty sleeping, memory issues, obsessive thoughts and OCD behavior, auditory issues.
Febrile seizure on 5/23/2022.  Duration 2 minutes.   Evaluated at Emergency Department.  Temperature 101.7 rectally in the emergency room.   No lab work or imaging performed.  Symptoms resolved spontaneously.
Patient came to an offsite event to receive his 2cd dose of vaccine. Patient did not have his vaccination card. We administered the moderna vaccine. When we tried to bill the insurance later that day the claim rejected because he had already received the j&j vaccine. We called the patient to inform him to contact his dr to let them know what transpired.
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the physician for himself. The age at vaccination was not reported. The patient experienced mild injection site pain after receiving SHINGRIX. The patient called for a different reason and mentioned in passing about his mild pain. The reporter did not consent to follow up.
Lost hearing in left ear approximately 10 hours after receiving vaccine. Still has not returned. No treatment has been sought yet.  Currently 7 wks pregnant. Due September 21, 2022.
Over the first week I experienced nothing. On the morning of March 13, 2021 I awoke feeling unwell and while walking to the toilet from the bed experienced some nausea and unsteadiness on my feet. This needs to be continued to cover the second dose!!
Vaccine 9/21/13 developed rash on neck 9/22/13. Progressed throughout body 9/24/13.
Weakness, nausea, stomach cramps, extreme fatigue, headache. Symptoms lasted five days.
Pt. complained of a fine red rash to arms, abdomen, and chest approx 10 hrs after receiving Gardasil vaccine. Pt has been taking Benadryl, Claritin, and Medrol dose pack.
mini stroke; high blood pressure; difficulty recalling word; dizziness; no control over body; Shaking Arms; weakness; right side  jaw pain; soreness; exhaustion; throbbing; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Feb-2021. The most recent information was received on 12-Jul-2021 and was forwarded to Moderna on 12-Jul-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (mini stroke) and HYPERTENSION (high blood pressure) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016ZMOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced HYPERTENSION (high blood pressure) (seriousness criterion medically significant), MEMORY IMPAIRMENT (difficulty recalling word), DIZZINESS (dizziness), DYSKINESIA (no control over body), TREMOR (Shaking Arms), ASTHENIA (weakness), PAIN IN JAW (right side  jaw pain), PAIN (soreness), FATIGUE (exhaustion) and HEADACHE (throbbing). On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (mini stroke) (seriousness criterion medically significant). The patient was treated with ALPRAZOLAM (XANAX) at a dose of UNK, qd. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (mini stroke), HYPERTENSION (high blood pressure), MEMORY IMPAIRMENT (difficulty recalling word), DIZZINESS (dizziness), DYSKINESIA (no control over body), TREMOR (Shaking Arms), ASTHENIA (weakness), PAIN IN JAW (right side  jaw pain), PAIN (soreness), FATIGUE (exhaustion) and HEADACHE (throbbing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication detail was reported.  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.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: follow up received and Updated reporter contact information. On 01-Jul-2021: The follow up document contain no new information. On 12-Jul-2021: Added newserious event (transient ischaemic attack).; 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.
Potential use of expired Pfizer Pediatric Vaccine. Received information from the manufacturer indicating that stability data supports the use of this product for 18 months.
8/1/06:  DTaP and PCV7 (4th doses in series for both vaccines)given at 8:30 am.  At approximately 7pm mother noticed 8-10 bumps on face and arms.  Gave BENADRYL.  Had low grade fever.  Patient slept through night.  8/2/06:  Awoke at 6:15 am with rash and hives over entire body.  Temp 99.6 axillary.  Saw family MD at 8:30 am.  Prescribed PRELONE 15/5 and gave instructions to use ADVIL and BENADRYL as needed.  No local reactions reported.
Rash, non pruritic on body.  No other symptoms.  Tx with Benadryl x 2 and rash resolved.  Rash did not have the appearance of urticaria.
prolonged (2.5 weeks currently) pain and loss of range of motion in SHOULDER.
The day after vaccines developed redness around (R) thigh. Started Benadryl but redness increased, and also developed another red rash on (L) thigh. She also started wheezing and was treated w/ Prednisone.
No additional adverse events reported.; Medical Assistant reporting the administration of expired VAQTA and inquiring viability of the administration of expired dose. No additional adverse events reported. No product quality complaints reported. No further details provided.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 18-APR-2022, the patient was vaccinated with expired dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 ml, lot # T033304, expiration date 02-APR-2022 (dose number, frequency and route of administration were not provided) for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event). The medical assistant inquired viability of the administration of expired dose.
it was not given in my deltoid but in the fatty portion of my anterior upper arm; arm pain; redness on anterior part of her upper arm; A spontaneous report  was received from a physician concerning a female patient who was participating in the mRNA-1273 Emergency Use Program and experienced events like Inappropriate route of vaccination, Arthralgia and redness at anterior part of left upper arm.  The patient's medical history not provided. The concomitant medications included levothyroxine sodium, Vitamin D, Calcium and Prolia.  On 12th FEB 2021, the patient received their second of two planned doses of mRNA-1273 and the patient claimed that "it was not given in my deltoid but in a fatty portion of my anterior upper arm" for prophylaxis of COVID-19 infection.   The patient experienced onset of events like Inappropriate route of vaccination, Arthralgia and redness at anterior part of left upper arm. The treatment information included paracetamol.   Action taken with mRNA-1273 in response to the events was not applicable.     The outcome of the events unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2021 as dose 2, single (Lot number: EW0172) and on 12Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 44 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: my antigen tests still showed positive, but they were very faint lines and getting progressively fainter; (Sep2022) Positive, notes: antigen test result began showing a brighter positive line. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient experienced cough with phlegm in Aug2022 and is subsumed as Symptom under COVID-19. Patient did not had any known allergies.  No follow-up attempts are possible. No further information is expected.
Pt reported tingling, swelling in lips and tingling in arm 32min post vaccine.  Administered epi 0.3mg and 50mg IM Benadryl and called 911.  Pt transported to local ER awake, alert and breathing on his own.  Called ER 5 hours later.  Pt continued to be observed.  No more epi had been administered.
High fevers to 103 x 5 days.  Headaches.  Body aches.  Diaphoresis.
Generalized tonic clonic seizure, 6-7hrs after receiving vaccine. Afebrile.
Started feeling affects at 18:00 at night with bad headache. Took one low dose of 81mg of aspirin passed out soon after and was restless until midnight that night with chest pain. Took two lose dose aspirin and went back to sleep. woke up at 0600 feeling restless with chest pain and took one low dose aspirin. got back home at 0800 and feel asleep before waking up with crushing chest pain at 11:00 AM September 9th. chest pain when laying down, sitting, and standing. Went to Hospital Urgent Care and was told there by ER Nurse I needed to be taken to bigger Hospital Via Ambulance to ER. Was at ER From 1400 to 1900.
SWEATY; PAIN IN LEFT ARM; FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1), (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, 1 total administered, start therapy date were not reported for prophylactic vaccination.  No adverse events were reported following administration of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received a booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2 ) (suspension for injection, route of admin not reported, batch number: Unknown, and expiry: Unknown) dose was not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced sweaty, pain in left arm, and fever (dose number in series 2). Treatment medications (dates unspecified) included: Tylenol (paracetamol). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in left arm, sweaty, and fever. This report was non-serious. This case, involving the same patient is linked to 20220154210.
vomited about 3 times; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomited about 3 times) and DIARRHOEA (diarrhea) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced VOMITING (vomited about 3 times) and DIARRHOEA (diarrhea). At the time of the report, VOMITING (vomited about 3 times) and DIARRHOEA (diarrhea) 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. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Feb-2021 and was forwarded to Moderna on 12-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomited about 3 times) and DIARRHOEA (diarrhea) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced VOMITING (vomited about 3 times) and DIARRHOEA (diarrhea). At the time of the report, VOMITING (vomited about 3 times) and DIARRHOEA (diarrhea) 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.
Patient said that she felt sweaty, her heart was racing and that she thought it was a stroke.  She went to her primary care doctor who said that he thought it was a reaction to Fluzone HD.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies reported. On 15-SEP-2016, a temperature excursion during the storage of PROQUAD took place. Temperature was of -10.9 Celsius degrees for 90 minutes. Data logger was involved. There was no prior excursion. Since that date, unspecified number of patients was vaccinated with unspecified number of doses of improperly stored PROQUAD, lot # M014304, expiration date: 22-SEP-2017 (dose and route were not provided). There were no adverse events reported. There was no product quality complaint (PQC) involved. This is one of two reports received from the same source. Additional information has been requested.
pt c/o head and chest itchiness, Benadryl given @ 12:36. VSS  1300 pt stable, no itching. Pt discharged to home.