chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm bruised at injection site 3 weeks post vaccine; had bleeding immediately post injection first dose; This is a spontaneous report from a contactable Nurse. A 38-years-old male patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: ER8730) via intramuscular route of administration in Left arm on 13Apr2021 at 09:30 AM (at the age of 38-years-old) as dose 1, single for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The patient experienced arm bruised at injection site 3 weeks post vaccine on an unspecified date; had bleeding immediately post injection first dose on 13Apr2021 at 09:30 AM. The outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Information has been received from a physician concerning a 10-year-old female with no pertinent medical history or allergies, who on 26-JUN-2006 was vaccinated with a second 0.5 ml dose of Varivax (lot# 635207/0075K). It was noted that the first dose of the vaccine had been given 5 to 6 years earlier. There was no concomitant medication and it was reported that the vaccine had been stored at the correct temperature. On 05-SEP-2006, possibly following exposure to varicella at school, the patient experienced a breakthrough rash, less than 50 lesions. The rash was described as erythematous and papular and progressing to pustules. Unspecified medical attention was sought and the patient was clinically diagnosed with varicella; no laboratory or diagnostic studies were performed. At the time of the report the patient had not recovered. No product quality complaint was involved. The reporter requested more information on the lot number. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agency. Additional information has been requested.
2/09 - Pt called w/ c/o redness, edema & warmth down left arm. Took BENADRYL & cold compress w/no change in sx given rx for oral prednisone and flu in office on 2/10/12.
Within 12-14 hours after Zostavax, the next morning woke up with a cold sore blister.  Went away in 48 hours.  Usually his cold sore blisters last 4-5 days.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On 14-JUN-2010, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On 04-AUG-2014, the patient was treated the same physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
A report was received from a healthcare professional on 03 December 2003, concerning an 11 month old female vaccinee who was inadvertently administered Fluvirin on 02 December 2003. On 02 December 2003, the vaccinee inadvertently received Fluvirin.  No adverse effects were reported at the time of report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Pt recv vax on 12/9/98; 15 min post vax pt exp dizziness, nausea, rigid, cyanotic, frothing at mouth x 2 min
Pt had the flu vaccine before with no reaction. Pt stated that she thinks last time was not FLUZONE HD, but at the same time she was on antibiotic therapy. Dr was trying to rule out if the allergic reaction was to antibiotic hx and not from FLUZONE.
Itchiness; Rash that was two inches from the injection site, but is spreading; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE RASH (Rash that was two inches from the injection site, but is spreading) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 28-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE RASH (Rash that was two inches from the injection site, but is spreading) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE RASH (Rash that was two inches from the injection site, but is spreading) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
pt recvd vax on 5DEC94 & on 6DEC94 pt presented w/fine red lesions flat on lt upper extremity & on rt & lt lower extremities pos pruritic rash lasted x 2 days;
RASH ON RIGHT ARM AROUND INJECTION SITE.  ITCHINESS BEGAN ON 2/21 AND THE FOLLOWING MORNING DEVELOPED SMALL RASH THAT HAS SEEM TO HAVE GROWN. AS OF THURSDAY THE ARM STILL EXHIBITS THE RASH.  HAVE HAD AN ON AND OFF AGAIN HEADACHE.  NOT SURE IF THAT IS RELATED TO THE VACCINE.
Approximately one week post vaccination she began to experience progressive vision loss in her left eye, Left jaw pain, left temporal pain. Maxillary sinus disease discovered incidentally at this time.
1/5 vaccination 1/6 woke up dizzy, nausea, no fever. By 10am I felt fine.  1/7 loss of taste and smell. Lasted for 11 days.  *were exposed to possible COVID+ patients; 2 days prior to vaccination, both tested negative Advised  COVID rapid test; negative  Loss of taste for 11 days.  2/5 second vaccination
Nightmares, hallucinations, tearing off her clothes, screaming outbursts lasting a few hours with reoccurrence of acute episodes triggered by wearing clothes.
but four months later 31May2021 I woke up at 2 am to a burning arm and red arm; I had a white area where shot was given.; About two minutes after injection, my hands and feet started burning and itching.; itching; This is a spontaneous report received from a contactable healthcare professional (herself as patient) reported that a 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 22Feb2021 07:30 (age at the time of vaccination 44-years-old), (Batch/Lot Number: EL9262) in the arm left as a DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included hypothyroidism and allergies: coconut oil; both since from an unknown date and unknown if ongoing. Concomitant medications included omeprazole (Strength: 40 mg), levothyroxine and zoloft. The patient previously took moxifloxacin and avelox and experienced allergies. The patient was not pregnant at time of vaccination. The patient was not requiring Hospitalization Prolonged. The most recent COVID-19 vaccine was administered in the hospital. The patient does not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. On 22Feb2021 07:32, it was reported that about two minutes after injection, my hands and feet started burning and itching, itching. On 31May2021 02:00 it was reported that but four months later 31May2021 I woke up at 2 am to a burning arm and red arm and I had a white area where shot was given. The clinical outcome of event extremities burning sensation of and pruritus was recovered on an unknown date in 2021. The outcome of the events erythema and vaccination site pallor was recovered on 01Jun2021.
Vertigo; dizziness accompanied by being light headed; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9809) via an unspecified route of administration in the left arm on 09Feb2021 at 14:15 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies. 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. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), chlortalidone (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), vitamin d not otherwise specified (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 19Jan2021 at 14:15 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. On 23Feb2021 at 05:30, the patient experienced vertigo and dizziness accompanied by being light headed started 14 days after the second dose. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vertigo and dizziness was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pain, redness injection up radiating up neck. Presented to ER on 8-30-17 (PM). Admitted, discharged 9-1-17 9PM-"Bell's Palsy" on discharge papers.
Approx 6 hrs p/vax given pt was sleeping; mom noticed pt seemed to be gasping for breath; mom waked pt but it took a minute or two to get pt awake & alert; pt woke screaming & cont to scream for a few minutes;
On the day following dose #2, developed the following symptoms: chills, fever (Tmax 103F) -- required OTC tylenol, resolved after 24 hours myalgias with severe muscle weakness that impaired my ability to walk up and down stairs -- weakness resolved after 24 hours, but myalgias resolved after 72 hours headache -- resolved after 24 hours nausea/anorexia -- resolved in 72 hours fatigue -- resolved in 24 hours  Symptoms severe for the first 24 hours that I was unable to work
Migraine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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, the patient experienced MIGRAINE (Migraine). At the time of the report, MIGRAINE (Migraine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported
This spontaneous prospective pregnancy report as received from 23 year old female consumer with penicillin allergy, for GARDASIL, a pregnancy registry product, concerning herself. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with a dose of GARDASIL (dose, route and lot # not provided) on 02-OCT-2012 and on an unknown date she had spotting. The patient also indicated she was pregnant. The LMP and EDD were not known. Initial exposure to GARDASIL was not reported. On 20-DEC-2012 blood work was performed (result unknown). No treatment was given for the events. The patient did not seek medical attention. Therapy was discontinued. The outcome of spotting and pregnancy was unknown. The relatedness between the spotting and GARDASIL was unknown. Additional information is not expected.
Administered Sept 6 - 2011. 5 days later - severe swelling eye area, itching, redness (face), extreme dry skin (face) and peeling (9 days).
Nausea; Fever of 102F; Body aches; Headaches; Vomited; She was really "put down"; Has barely eaten; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (She was really "put down"), DECREASED APPETITE (Has barely eaten), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever of 102F) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced CHILLS (Chills). On 13-Mar-2021, the patient experienced ASTHENIA (She was really "put down"), DECREASED APPETITE (Has barely eaten), NAUSEA (Nausea), PYREXIA (Fever of 102F), MYALGIA (Body aches), HEADACHE (Headaches) and VOMITING (Vomited). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (She was really "put down"), DECREASED APPETITE (Has barely eaten), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Body aches), HEADACHE (Headaches) and VOMITING (Vomited) outcome was unknown and PYREXIA (Fever of 102F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: high (High) 102 F.         The action taken with the drug in response to the event(s) was not applicable.   This case was linked to MOD-2021-019543 (Patient Link).
Per interview with Patient's son, Patient had covid 6 weeks ago (no record in State database),and recovered. On 3/29/22, Patient was found unresponsive in his home, transported via ambulance to hospital, dx'd L-hemi brain bleed. Patient was DNR, discharged to home hospice, then passed away on 3/31/22.
May 6 2021-midnight-  Approx 8 days after vacc, severe back pain and leg weakness, legs weak and shaky to the point of not being able to get out of bed due to pain and weakness. Took Tylenol and later IB, with no real relief until day 3.   resolving at day 6-   May 11- 2021-developed fever, chills, skin sensitivity. Fever on 5-11-21 to 101.9 lasted for 2 days- severe headache, weakness, legs still weak and shaky, to the point of going up and down stairs is still very difficult. Day 16-  5-13-2021 some sx resolving, back pain and legs still shaky/weak. fever gone, headache still comes and goes. Missed a week of work as a store mananger
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 26-AUG-2015, the patient was vaccinated with an improperly stored dose of VAQTA "10pk 25U/0.5ml SD LLok wCap Ped" which had a lot number of L013324 and expiration date on 24-APR-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the VAQTA vaccine had one temperature excursion for 24 hours. The lowest recorded temperature was 33 F (0.555555556 Celsius) and the highest recorded temperature was not mentioned. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 12 years old adolescent patient and unknown gender. On 10-SEP-2014 the patient was vaccinated with first dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
16DEC93 gradual onset leg & back pain-achy-numbness in legs when sitting; 17DED92 5PM-no feeling below knees, extreme joint pain, numbness if up too long; 19DEC93 sx resolved;
pt woke @ 3AM 16DEC92 crying & feverish; pt began jerking all over, eyes rolled back & salivating; taken to ER adm until 9PM same day;
Pt had pain starting in the neck and going up to the head starting about 9 hours after the shot. She says she also had fever, chills, and body aches at that time. The neck was hot to the touch.  As of 5/16 the fever had gone down, but the neck is still hot to the touch. Pt also says her neck and body still hurts. She has tried taking ibuprofen which helped somewhat. The neck pain is her primary concern. She was going to call Dr. this morning 5/17.
Pt. became very dizzy, weak, and shaky. stated she felt like she couldn't open her eyes or move her legs. was placed in supine position with legs elevated. Pt only had some chips-nothing to eat. sugar water given with no improvement. VSS-pt taken to ER for further evaluation (by mother)
85 y/o F NKA, PMH: Dementia, Hypertension, CVA,OA/DJD, hyperlipidemia  Patient also has h/o stroke. Patient was admitted for fracture following mechanical fall.                                                       ?  One day prior to discharge patient is given a flu shot. Within 20 minutes, patient developed acute changes in mental status.  Patient was slow to respond. Patient also had some finger numbness but patient had this symptom prior to receiving shot. Patient was negative for h/a, weakness, change in movements, no focal neurological deficit was observed. Patient did present some dyspnea, Xray did not reveal any cardiopulmonary disease. RR and O2 sat WNL.  ? Patient had received flu shots in the past w/o difficulty. ? Patient was transferred to monitored bed. Other possible reasons for sudden AMS: questionable sun-downing , pain ????   ? Other medications administered prior to flu shot: Roxanol 03:30, 08:45.  Percocet:06:00, 12:00, Saline flush:06:00, 16:00 ? Flu shot administered at 16:25 IM to left deltoid. (MFR:Glaxo SMK Lot:881175P
1st day bloated stomach repeated burped, weakness, h/a;2nd day blurred vision, SOB, numbness of lips & tongue, slurred speech, erratic walk;
approximately 5 minutes after the injection my upper lip went numb along with my left side of my face, primarily my upper cheek below my eye.  Then it slowly moved to the top of my head and the top of my left hand.  My heart was racing a bit, but that could be due to me being nervous about my face going numb.    An attendant stayed with me until it started to subside, approximately 15 minutes later.      Other side effects were mild the following day.  A bit of a headache, fatigue and chills.  Fatigue lasted a couple days but all minor.
Very lower back to upper gluteus maximus  area slight discomfort. Like I have been sitting for too long.  Feeling better today on 9/19/22.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
I woke up with a Sore throat, a headache, and chills. I developed a bad cough that hurt in my chest when I coughed.  By day 2, there was bad fatigue with fever peaking at 102. Over the course of the day, I got joint stiffness in my arms and I had some dizziness. 12/27 Tested on an At Home COVID-19 test, positive. Tele-visit with Doctor who recommended treating symptomatically. I felt ill for 7 days and then the symptoms gradually improved over the next 7 days. Sinus pressure and congestion, and cough lingered slightly more, cough lingers to time of reporting. Nasal drainage is not as it was it was. Doctor proscribed Zyrtec, Potassium, and hydrochlorothiazide to help address lingering symptoms.
I got my 1st dose at 9:35 A.M., then at 5:00 P.M. I started to felt slight fatigue, then continued to super fatigue. I took my blood pressure, first it reach 150/84, then 20 minutes after it reached 160/90 which made me concerned. And I was so real fatigue. So I lay down. The whole night of 4/12/21, my BP was high 145/84, 150/84.  I had a slight feeling of body cold, so i dressed warm. The following day which is 4/13/21, my BP is still high in between 140/84 to 150/84.  On 4/14/21, my BP was 145/84 which a bit bitter compared to the previous days.
aspetic meningitis 26 days p/OPV; resp failure w/bulbar paralysis; still ventilator dependent w/paralysis of lt diaphragm; minimal patchy recovery of motor function; cannot swallow; quadriplegic;
1 week after injection I had severe pain in right arm, that continues to today, and severe noise in ears. Pharmacist suggested I clean my ears, that it was either wax buildup or allergies.  I made an appointment with my medical DR who checked me over, and did a hearing test, and then proceeded to refer me to an ENT. The ENT did much deeper tests, said I lost 50% hearing in right ear and 30% in left ear and that because of the amount of time that passed, there was nothing he could do to help me recover it. He said he has seen this in many women, post COVID vaccine. Now I have to be fit for hearing aids, to wear for the rest of my life, because of a vaccine I didn't want to get to begin  with. I refuse to get the second one, because I may lose the rest of my hearing .