chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Splotchy rash and bumps on stomach, feet, legs.; Very itchy feet and itching around body; Head feels a little foggy.; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6204), via an unspecified route of administration in the left arm on 24Mar2021 at 11:00 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not take any concomitant medications. The patient previously received azithromycin (ZITHROMAX) and amoxicillin (MANUFACTURER UNKNOWN); both on unknown dates for unspecified indications and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 24Mar2021 at 18:30, the patient experienced splotchy rash and bumps on stomach, feet, legs, very itchy feet and itching around body and head felt a little foggy. It was unknown if any therapeutic measures were taken as a result of the events. The clinical outcome of the events rash, itching and foggy feeling in head was unknown at this time of report.   No follow-up attempts are needed. No further information is expected.
sick to her stomache; dizzy; blurry vision, didn't last very long, laid down, and then she was fine; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (sick to her stomache), DIZZINESS (dizzy) and VISION BLURRED (blurry vision, didn't last very long, laid down, and then she was fine) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included TRAZODONE for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (sick to her stomache), DIZZINESS (dizzy) and VISION BLURRED (blurry vision, didn't last very long, laid down, and then she was fine). At the time of the report, ABDOMINAL DISCOMFORT (sick to her stomache), DIZZINESS (dizzy) and VISION BLURRED (blurry vision, didn't last very long, laid down, and then she was fine) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.; Sender'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
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A 14-month-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: FT9142) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; RASH (non-serious), outcome "unknown"; NASAL OEDEMA (non-serious), outcome "unknown", described as "Swollen up nose"; INCREASED APPETITE (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, rash, nasal edema, increased appetite. Additional information: Reporter stated, calling to report an adverse side effect for Pfizer vaccine for reporter's one year old. Later when probed for age at onset of events, reporter stated, 14 months. When probed for the side effects, reporter stated, fever, rash, swollen up nose, increased appetite. Height and weight: Reporter stated, not sure about the height and the weight was probably around 25 pounds. Expiration date: Reporter stated, It was not on the form. Reporter do not see it on the form. Treatment: Reporter stated, No. Prior vaccinations: Reporter stated, She did not. No other products. Reporter queried, Okay was she safe to get Tylenol for her fever or was she safe to get a second dose.
Patient reported productive chest cough starting same day as influenza vaccine administration; attempted to follow up with primary physician.  After two attempts was seen in ED/UC. Overall well appearing to ED physician; chest x-ray indicated  likely right lower lobe infiltrate consistent with pneumonia. Treated with Doxycycline 100 mg bid for 7 days.
Vomiting; Diarrhea; Fever; Knee and ankle pain; Fatigue; Headaches; Dehydrated; This is my 3rd dose; This is my 3rd dose; This is a spontaneous report from a contactable consumer. A 45-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FL 3183), via an unspecified route of administration, administered in Arm Left on 25Sep2021 13:45 as DOSE 3, SINGLE for covid-19 immunisation (at the age of 45 years). Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. Medical history included rubber sensitivity from Latex , drug hypersensitivity from Penicillin and Sulphate. Concomitant medications included doxycycline and tessalon perle. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. The patient previously took first and second dose of BNT162B2 for covid-19 immunisation. The patient experienced vomiting, diarrhoea, fever, knee and ankle pain, fatigue, headaches, dehydration, off label use and immunisation on 25Sep2021 16:45. Since the vaccination, the patient had not been tested for COVID-19. Treatment received was unknown. The clinical outcome of the events was recovered for vomiting, diarrhoea, fever, knee and ankle pain, headaches, dehydration and unknown for Off label use, booster, fatigue.  Follow-up (28Sep2021): Follow-up attempts are completed. No further information is expected.
I already received the 1st dose of the vaccine. We had a painter that did work in our house and he has been diagnosed with COVID, we're currently under quarantine; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (age 78, unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation (COVID-19 Vaccine). The patient medical history and concomitant medications were not reported. The patient experienced I already received the 1st dose of the vaccine. we had a painter that did work in our house and he has been diagnosed with covid, we're currently under quarantine (non-serious) on an unspecified date. Question: I already received the 1st dose of the vaccine. We had a painter that did work in our house and he has been diagnosed with COVID, we're currently under quarantine. I'm supposed to get the 2nd dose of the vaccine on Wednesday, 10Feb2021. Would it be okay for to take it on that day or should I wait until quarantine is over? Please help me. Would it cause harm if you got the first dose, and you didn't get the 2nd dose? The outcome of event was unknown.  Information on the lot/batch number has been requested.
Full itchy; rash, broke out again; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Full itchy) and RASH (rash, broke out again) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart attack (Patient had heart attack twice from heart racing) and Heart racing (Patient's heart races due to Hashimoto's disease condition). Concurrent medical conditions included Allergy, Eczema, Thyroid disorder (It was not clear whether it was hyperthyroidism or hypothyroidism, because patient mentioned both) and Hashimoto's disease. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (Full itchy) and RASH (rash, broke out again). At the time of the report, PRURITUS (Full itchy) and RASH (rash, broke out again) outcome was unknown.            Patient had rashes from anything, she was even allergic to band-aids, so she didn't not blame the vaccine but rather her own skin.  Since hear attack patient couldn't control it only with thyroid medication cardiologist told her to have aspirin daily as well.   This case was linked to MOD-2021-286205 (Patient Link).
Patient began to feel hot, vital signs were assessed and patient was found to be tachycardic and flushed.  Given history of other allergic reactions and rapid onset of symptoms, patient was sent to the ED for additional f/u.
pt recvd vax 18JUL94 & according to parent, on 21JUL pt had 2 small convuls (arms & legs shook for approx 30 seconds);parent informed physician's office of 22JUL but mom declined office visit;pt recovered;
received his Pediarix vaccine and was prescribed a HIB vaccine as well, but was instead administered a Pentacel vaccine, with no reported adverse event; Initial information was received on 12-Apr-2021 regarding an unsolicited valid non-serious case from a other health professional ( Inquiry number: 00557376).  It was reported that vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: S006471 ) (Suspension For Injection) was administered to a six-year-old male patient instead of HIB vaccine on 09-Apr-2021 via intramuscular route at right thigh for prophylactic vaccination (wrong product administered).  It was a case of actual medication error due to wrong vaccine administered.  On an unknown date, the patient received a dose of suspect PEDIARIX not produced by Sanofi Pasteur.  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report was received from a medical assistant and a office manager referring to five patients of unspecified gender and age. In February and March 2017, five patients were vaccinated with improperly stored doses of VAQTA lot number M033611, expiration date 02-MAR-2018 or lot number M036459, expiration date 18-JAN-2018 (formulation, dose, frequency, route of administration and indication were not reported). No adverse effects were reported. The doses were stored in temperature between 47 degrees Fahrenheit to 77 degrees Fahrenheit for 61 hours. Data logger was involved. There was no previous excursion reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA008878.
This spontaneous report was received from a healthcare worker and a licensed nurse practitioner refers to a patient of unspecified age and gender. On 07-MAR-2014, the patient was vaccinated with a dose of improperly stored VARIVAX (lot# J002618, expiration date: 01-MAR-2015, 0.5 milliliters (ml), subcutaneous) (strength and indication not reported). The VARIVAX has been stored at -10 C (Celsius) above recommended temperature range in product information) since July 2013. No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
a little bit of hip and back pain; a little bit of hip and back pain; Such pain she couldn't stand up or walk; Such pain she couldn't stand up or walk; Such pain she couldn't stand up or walk/Noticed increase in her pain; This is a spontaneous report from a contactable nurse. A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6203, expiration date: Jun2021), via an unspecified route of administration on 03Mar2021 as single dose for COVID-19 immunization and for autoimmune deficient. Medical history included sjogren's syndrome, rheumatoid arthritis from 2016 (reported as about 5 years ago), hip replacement, autoimmune deficient from 2007, and hip dislocates three times a year. Concomitant medication included tofacitinib ongoing citrate (XELJANZ XR, lot number: DR2042, expiration date: 31Jan2023), hydroxychloroquine, pregabalin (LYRICA), all three for unspecified indication. On 04Mar2021, the patient noticed increase in her pain. Such pain that she couldn't stand up or walk. The patient also had a little bit of hip and back pain on an unspecified date. The patient clarified that she has oxycodone as pain medication (med). The patient stated that she has too many medications that she has to take. Stated that her brain was dying. The patient also stated that she was doing fine and hasn't had pain like this. The patient did not know if it was an adverse reaction or what. The reporter seriousness for such pain she couldn't stand up or walk was assessed as disabling. The outcome of the events was unknown.; Sender's Comments: The causal association cannot be excluded between the reported events and vaccine use based on strong temporal association. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for AE. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
This was a THERAVAX Rational Vaccines trial vaccine given outside the country. 7/11 arrive for second shot in right calf THERAVAX vaccine. 7/12 headache very tired pm 4pm feel 5. 7/13 better but large bulls-eye leg rash. 7/14 severe HSV2 outbreak :(7pm). 7/15 finger pain first section. Nerves joint shooting pain achy. 7/15 fingers jaw back ache Nerves. 7/17 lower back pelvic Spine shooting pain sciatic? Joint? 7/21 Shooting pain HSV flare up again headache significant random itchy all over. 7/22 random itching all over. 7/31 numb, tingling arms legs, weak muscles, shaking tremors, hard to hold phone. Breath shortness. Like everything going to sleep. 8/1 same. 8/2 arthritis settle in lower back. 8/4 feel slightly better. 8/6 attempt HSV outbreak. 8/6 shooting aches elbow thighs very swollen lymph nodes neck and jaw fingers sickly aches in small sections and joints fingers. 8/15 mild shooting aches thigh arms lower back aches and upper arms. These random symptoms continue to current date. Continued unusual HSV outbreaks, prickly skin and tiny red dots in odd places. Chronic aches.
Moderna COVID-19 Vaccine EUA Patient was given dose after the puncture expiration time had lapsed.
erythema multiforme reactions; This literature-non-study case was reported in a literature article and describes the occurrence of ERYTHEMA MULTIFORME (erythema multiforme reactions) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: (Privacy)  No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ERYTHEMA MULTIFORME (erythema multiforme reactions) (seriousness criterion medically significant). At the time of the report, ERYTHEMA MULTIFORME (erythema multiforme reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ERYTHEMA MULTIFORME (erythema multiforme reactions) to be related.    Treatment and concomitant medications were not reported  Company Comment - This regulatory authority case concerns a 61 year old male patient with no relevant medical history, who experienced the serious unexpected events of erythema multiforme. The event occurred on an unknown date after a dose of mRNA-1273 vaccine, the outcome was unknown at the time of the report. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-475711 (Patient Link).; Sender's Comments: This regulatory authority case concerns a 61 year old male patient with no relevant medical history, who experienced the serious unexpected events of erythema multiforme. The event occurred on an unknown date after a dose of mRNA-1273 vaccine, the outcome was unknown at the time of the report. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report
corneal abrasion; patient accidentally had some of the Pfizer COVID-19 Vaccine in her eye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), ophthalmic (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: CORNEAL ABRASION (non-serious), outcome "unknown", described as "corneal abrasion"; ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), outcome "unknown", described as "patient accidentally had some of the Pfizer COVID-19 Vaccine in her eye". Therapeutic measures were taken as a result of corneal abrasion. Additional information: The caller on the line was a non-HCP assistant who was reporting that a patient accidentally had some of the Pfizer COVID-19 Vaccine in her eye. The caller stated that if information could only be given to an HCP she could put Physician Assistant (name withheld) on the line. This HCP then stated that the patient eye was washed for 2 minutes and that the patient had corneal abrasion, but was fine in every other aspect. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Right arm has lost strength and ability to grasp items. I am having tremors in my hands and have to use bothe hands to hold a drink to not spill. I cannot perform normal things with right hand like opening doors or getting keys out of pocket.
11MAY94 pt recvd vax & slept till 5PM woke up vomiting & t103 R; APAP given; pt had grunty resp & would quit breathing & start again; pt taken to ER CXR done;
Patient received 2nd dose of vaccine 5 days earlier than recommended (day 16 vs day 21).
The day after flu vaccine patient had erythematous maculopapular rash on neck R.L blanches with compression.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 30-MAY-2013 the patient was vaccinated with the first 0.5 ml dose of M-M-R II (HSA, lot # 669840/0446AA, expiration date 28-MAR-2013), subcutaneous. No adverse effect reported. Additional information has been requested.
Cough, generalized weakness, headache and feeling of dehydration, fever, chest pain, fatigue
Seizure like episode on 1/12/21, one week after vaccine, last 1.5 hours, consisting of both eyes twitching and clenching/spasm of right hand and arm.  EMS called.  BP normal.   Continuing weakness of right arm and right leg, which was side weakened by stroke.  Could no longer stand or walk on right leg.  Some slurring of speech. Some confusion.  Went to hospital 1/14.  No evidence of stroke or current seizure.  Considered problem to be mild UTI, started antiobiotics, rapid improvement.  Discharged 1/17. Woke up 1/18 with aphasia.  Went to urgent care, sent immediately to hospital.  Doctors found no evidence of stroke or seizure.  Consider problem to be due to inflammation, caused by mild UTI (which was cleared by antibiotics) or perhaps due to inflammation caused by Covid vaccination.  The inflammation reinitiated the symptoms of her stroke, although she never had expressive aphasia prior to this, only word-finding problems, which had been resolved.
Patient received Pfizer's <5 Bivalent COVID vaccine as the second dose instead of the <5 Monovalent. No adverse effects noted.
Patient stated that 2-3 hours after vaccine was administered he developed swelling around the eyes, a productive cough and a lot of pain in the arm the vaccine was administered.  He said symptoms lasted for 2-3 hours from the time that the symptoms started.
PT FILLED OUT THE CONSENT FORM FALSELY INDICATING SHE NEVER RECEIVED  COVID VACCINE PREVIOUSLY AND I WENT AHEAD AND GAVE HER PFIZER COVID SHOT  PER HER REQUEST. LATER WHILE PROCESSING THE FORM I GOT FLAGGED SHOWING THAT SHE HAD ALREADY GOTTED JANSSEN COVID 19 VACCINE ON 3-6-21. THEN I CALLED HER TO CONFIRM THAT AND SHE CONFIRMED THAT YES SHE GOT JANSSEN COVID 19 VACCINE PREVIOUSLY BUT SHE FALSELY INDICATED SHE NEVER GOT ANY SO SHE CAN GET THE PFIZER SHOT.
VACCINE RECIPIENT RCD 2 PFIZER C- 19 VACCINE DOSES PRIOR TO THIS, ON 12-18-2020 AND 1-7-2021, WITHOUT ADVERSE EFFECTS. ON 7-31-2021 AT A SPONSORED HEALTH PROMOTION AT, RECIPIENT WAS TESTED FOR COVID IGM AND IGG ANTIBODIES BY AN OU RESEARCH IMMUNOLOGIST AS PART OF A GRANT-SPONSORED STUDY.  HER IGG ANTIBODIES WERE REPORTED AS VERY LOW. AS THE CLINIC WAS CLOSING,  THERE WERE PFIZER C-19 VACCINE DOSES TO BE WASTED.  THE RECIPIENT REQUESTED A 3RD DOSE (BOOSTER) AND THE VACCINE COORDINATOR (VC)APPROVED IT BASED ON RECIPIENT'S LOW IGG RESULTS,  RECENT REPORTED STUDIES AND VACCINE THAT WOULD BE WASTED.  THE VC DID NOT HAVE AUTHORITY TO APPROVE THIS BOOSTER DOSE.
Fever, significant chills, significant full body ache, rash that covered from my waist up.  Also a ring around the injection sight on my left deltoid.  Approx 2? radius around the site.
Right back from MOB. The signs appears. Hospital is been taking care my symptoms like Thyroids, High Cholesterol, and Memory Lost.
Immediate tingling in the arm/down to the finger tips, arm/hand/fingers feels asleep and heavy 24/7
isolated to the left sided chest pain 8 hours later. non radiating. feels better when she touches it
Narrative: He was sent to the ER from the vaccination clinic for complaints of feeling flushed/SOB. He reports that he was treated with Prednisone/Benadryl and released from the ER. He reports that he was given a script for Prednisone 50 mg po TID, QTY 3. Patient reports that he is still with some symptoms today such as diarrhea, feeling flushed, headache, intermittent periods of SOB.  Other Relevant Hx: Severe COPD, Panic disorder Symptoms: Tachypnea, Diarrhea & FLUSHING, SHORTNESS OF BREATH, RESP RATE 22 Treatment: DIPHENHYDRAMINE ,METHYLPREDNISOLONE