chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had pfizer booster on 11/28/21 and 1 week later started developing an itchy eruption.  OTC medications did not help so she came to see me on 12/10/21.  at that time I considered vaccine hypersensitivity reaction and gave her strong topical steroid and had her come back on 12/14/21.  At thie visit the eruption had spread up and down her legs, it was erythematous and violaceous, a few lesions felt raised and she complained of itching and pain.  I then did a punch biopsy of one lesion and sent her for lab work.  She was subsequently diagnosed with polyarteritis nodosa.  I started her on prednisone 60mg daily right away and had her follow up with her PCP and rheumatologist, who lowered prednsione dose to 20 and started colchicine 0.6mg bid.  She is still on this therapy and doing better.  No new lesions, pain resolved and she will follow up with me and rheumatologist by end of January 2022.
devel fever, chills, flu-like illness dec appetite;some nausea/vomiting 2wk duration;onset 6-8 hr p/vax;
pt recv vax 26OCT98 & pt c/o sx AM 27OCT98 n/v x1, fever, all joints ache, chills;
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD albumin status rHa, lot # M032496, expiration date 02-JAN-2018 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursions from 15 degrees Fahrenheit to 46 degrees Fahrenheit (also reported as 34.4 degrees Fahrenheit) for 9 hours and 30 minutes and then from 15 degrees Fahrenheit to 46 degrees Fahrenheit (also reported as 25.3 degrees Fahrenheit) for 17 hours and 30 minutes. There was no adverse effect reported. The data logger was not involved. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA011668.
- Strong side effect the day of the vaccination and the day after. - Hospitalized due to possible heat attack and diagnozed with possible inflamation close to the heart or minor blood clots.
This spontaneous report as received from a physician refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients' were vaccinated with improperly stored doses of GARDASIL 9 (dose, and route not reported) from lot # M016193 with expiry date of 24-APR-2018. The vaccine was exposed to a temperature of 29.3 Fahrenheit for 16 hours and this was logged on a digital data logger. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Patient presented with dizziness and fainting. Pt worked up for syncopla episode.  Pt tested positvie for coivid before discharge. Pt discharged home.
This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 8-month-old male patient who received FLUARIX (batch number LZ4S2. expiry date 22nd May 2015). On an unknown date, the patient received FLUARIX. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration and wrong vaccine administered to be related to FLUARIX.
4/11/13 Day of vaccine. 4/12/13 Start to itch, turn red. 4/13/13 Hurt and turned red, pain a lot. Went to immediate care start BACTRIM DS - 2 a day / cold compress.
ACUTE RESPIRATORY FAILURE 3/1/2022,  8/1/2022,  12/3/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Janssen COVID-19 Vaccine EUA:  Immediately after the vaccination my arm was sore and shortly after my right hand was stiff.  About 8 hours after receiving the vaccination I began to have extreme chills and a fever that was near 102 F.  I had a fever and chills all night and woke up with a migraine.  After sleeping most the day from extreme tiredness I woke up to my head feeling very weird and I was acting very sleepy and irritable according to those around me.  After 24 hours, most  reactions have gone away except for soreness at the injection site and a pain in my right leg.
81-year-old female with a PMH significant for atrial fibrillation on Eliquis, hypertension, hypothyroidism who presented to the ER for evaluation of a BAM infusion. Vaccinated with Moderna x2 doses. Reportedly she tested positive last Friday with onset of symptoms Thursday with fevers/HA/SOB with productive cough, chest pain "some nights" intermittently with weakness. In the ER, her O2 sat was 90 % on RA, BP 99/76 for which she given IVF bolus. CXR was significant for small RLL infiltrate. Labs with elevated CRP and LDH. She is admitted to medical for further management.
PT RECEIVED VACCINES APPROX 1215PM, MOTHER CALLED TO REPORT PETECHIAE AROUND NECK AT 1625; MOTHER BROUGHT PT UP TO CLINIC TO ALLOW VISUAL EXAMINATION OF REACTION. PT DENIES ANY DISCOMFORT, DIFFICULTY BREATHING, ITCHING.  DOES NOT APPEAR ILL. MOTHER STATES WILL WATCH AN IF WORSE GO TO ER.  EMPLOYEE CONTACTED MOTHER AFTER LEFT AND SPOKE WITH MOTHER TO EDUCATE SIMILAR EVENTS FOUND REPORT ON VAERS AND THAT MAY WANT TO TAKE TO ER JUST AS RULE OUT/SAFETY PRECAUTION. MOTHER STATES IF GETS WORSE WILL TAKE CHILD TO ER.
Feeling dizzy; Broke out on a cold sweat; Started to feel really really tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling dizzy), COLD SWEAT (Broke out on a cold sweat) and FATIGUE (Started to feel really really tired) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 031L20A and 001B21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Started to feel really really tired). On 13-Nov-2021, the patient experienced DIZZINESS (Feeling dizzy) and COLD SWEAT (Broke out on a cold sweat). The patient was treated with LORAZEPAM for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Feeling dizzy), COLD SWEAT (Broke out on a cold sweat) and FATIGUE (Started to feel really really tired) outcome was unknown. No concomitant medications were provided. The patient took Lorazepam because she was really scared and anxious about the symptoms she have. This case was linked to MOD-2021-385992 (Patient Link).
Patient received his first Moderna Vaccine today.  The dose was given in his right arm and about 10 minutes after administration patient reported chest pain on the left side.  Patient was monitored and reported no signs of breathing problems, also no swelling, rash or problems with airways. Patients Blood pressure was taken and recorded as 141/91.  His pre vaccine temperature was 97.1, and he reported no allergies or health conditions. He is a 48 year old hispanic and smokes.  Patient agreed to have ambulance called to check him out as he had no need for Epi-Pen or benadryl. Paramedics arrived at the store approximately 10 minutes after called and released patient with no further treatment and stated that patient possibly had anxiety after the administration as he checked out on all other observations.
This spontaneous report as received from a registered nurse and refers to six children patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. On 21-FEB-2018, also reported as "22-FEB-2018, 23-FEB-2018 and 27-FEB-2018", the patients were vaccinated with an improperly stored dose of ROTATEQ orally, lot number N013989 with expiration date on 30-JAN-2019 and lot number N021101 with expiration date on 28-FEB-2019 (strength and dose were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion as listed, as recorded by a data logger. On 21-FEB-2018,  in the range between 32°F at 29 °F, worst case 1 hour. On 22-FEB-2018, in the range between 32°F at 30 °F , worst case 1 hour. On 26-FEB-2018, in the range between 32°F up to 35°F (32.44F), worst case 3 hours. On 27-FEB-2018, in the range between 32°F up to 35°F (32.46 F) worst case 3 hours. The vaccines had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1803USA004988:
POSSIBLE NEUROPATHY OR NERVE DAMAGE; ARTHRITIS TRIGGERED; SHOULDER PAIN; TINGLING; PAINFUL BASE OF THUMB; POSTMENOPAUSAL BLEEDING AND SPOTTING; NUMBNESS THAT WENT DIRECTLY TO ALL THE FINGERS OF HER RIGHT HAND; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: arthritis, non-alcohol user, non-smoker, and chocolate nuts allergy. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 23-JUL-2021 at right arm for prophylactic vaccination. No concomitant medications were reported.  On 23-JUL-2021, within a minute or two after vaccination the patient experienced numbness that went directly to all the fingers of her right hand. The patient reported that she could feel the numbness and tingling now only in her finger tips except for her index finger that was still numb. On 30-JUL-2021, the patient experienced menopausal bleeding that went on for 3 days. She described it as bleeding, spotting and cramps as if was about to have a cycle. On unspecified date, the patient experienced shoulder pain for a little over a week or 10 days, which was resolved. The patient also reported that the base of her thumb was painful. On 10-AUG-2021, the patient reported her symptoms to a physician who told her that it maybe Neuropathy or nerve damage and referred her to a Neurologist. The patient was prescribed Prednisone that she started on the day of this report on 11-AUG-2021. The patient also stated that she thought that the vaccine might have triggered her arthritis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from postmenopausal bleeding and spotting on 02-AUG-2021, and shoulder pain, had not recovered from numbness, and tingling, and the outcome of arthritis triggered, possible neuropathy or nerve damage and painful base of thumb was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210822953- covid-19 vaccine ad26.cov2.s-POSTMENOPAUSAL BLEEDING AND SPOTTING,POSSIBLE NEUROPATHY OR NERVE DAMAGE. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
I got extreme fatigue the next day after receiving my 2nd booster.  This has been going on for over a month. I am barely able to function and am a shadow of my former self.
10 days p/vax pt was stated by mom & grandma to have had a sz;child ran T102 placed in tub of ice until T and sz ended not reported to MD or hlth dept;
swollen eyes-lids & surroundings area;adrenalin, DPH left clinic in good condition-swelling resolved;
Fever; Headaches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headaches) and CHILLS (Chills) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014c21a and 046a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headaches) and CHILLS (Chills). At the time of the report, PYREXIA (Fever), HEADACHE (Headaches) and CHILLS (Chills) had not resolved.            No concomitant medications were used by patient.  No treatment medications were taken by patient.  Action taken with mRNA-1273 in response to the events was not Applicable.
I was diagnosed with shingles on May 10, 2021. I experienced my first spot on May 3, 2021, but I was unsure what it was. I have been otherwise healthy & would have no reason to contract shingles with my health and at the age of 33.
pt recv vax 10APR96 & 5MAY96 pt devel fever, swollen lymph nodes & clinical varicella, consisting of gen rash;
Splotchy rash around injection site 11 days after injection. Itchy, hot to touch, hard. Large diameter of rash.
MMR given in left arm at 5 minutes wheal developed under site given approximately 3cm x 4cm."
REDNESS AND SORENESS NEAR INJECTION SITE THAT WAS WARM TO TOUCH. THAT WENT DOWN IN THREE HOURS AFTER FIRST NOTICING THE REACTION AND WAS LESS THE NEXT DAY ON 10/27/16.
A few minutes after vaccination, patient noticed blood leaking out of her bandage.  As the pharmacist was cleaning up patient's arm and replacing the bandage, the patient lost consciousness for approximately 15-30 seconds. Patient regained consciousness and then was able to walk, then vomited. Patient was then seated by the pharmacy. Pharmacist attempted to check blood pressure, but got an error reading. Patient was given water per request. Patient vomited a second time. Patient seemed clammy and a bit pale. Per Pharmacist's best clinical judgment, EMS was called. Paramedics arrived about 1pm and decided to take patient to the hospital due to patient's low blood pressure readings and as a monitoring precaution.
.5 inch bruise at injection site, slight swelling,  sore muscle, ibuprofen,  ice bag,
flu like pains; chills; swelling on my lips; slight swelling right under my nose; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (swelling on my lips), INFLUENZA LIKE ILLNESS (flu like pains), NASAL OEDEMA (slight swelling right under my nose) and CHILLS (chills) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced LIP SWELLING (swelling on my lips) and NASAL OEDEMA (slight swelling right under my nose). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like pains) and CHILLS (chills). At the time of the report, LIP SWELLING (swelling on my lips) and NASAL OEDEMA (slight swelling right under my nose) had not resolved and INFLUENZA LIKE ILLNESS (flu like pains) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment was reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow-up information received on 02-JUN-2021 contains non-significant information. Email address was added
This spontaneous report was received from a other health professional referring to an unspecified number of patients of unknown age. On 06-SEP-2017, the patients were vaccinated with VAQTA for prophylaxis. On 06-SEP-2017, the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. This is one of two reports received from the same reporter. Lot number N002922 is an invalid lot number for [generic name of hepatitis a vaccine, inactivated]. Sender's Comments: US-009507513-1709USA003158: US-009507513-1709USA003178.
Myalgia, Diarrhea, NauseaVomiting, chills Narrative:
Swelling, redness, and hardness 9 days after vaccination at site of injection.  No pain or heating at site.  Lasted 2 days.  Was asked to provide the information to this site by the director of the clinic.
Bullous Pemphigoid; This is a spontaneous report from a contactable physician. A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) in Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included diabetes mellitus and hypertension; both were ongoing. The patient's concomitant medications were not reported. In Mar2021, the patient had bullous pemphigoid. The event was reported as serious (medically significant). Biopsy of the skin was highly suggestive for bullous pemphigoid on 05Apr2021; and COVID-19 antibody test was "qualitative positive" on 26Apr2021. The patient had received steroids (prednisone) and some topical cream as treatment for the event; then was prescribed with doxycycline ointment, doxycycline (oral), along with some other antibiotics, and niacinamide. The event had resulted into an emergency room visit and physician's office visit. The outcome of the event was recovering. The doctor wanted to know if Pfizer recommended the patient get his second COVID-19 Vaccine, since the patient had what appeared to be an autoimmune reaction to the first COVID-19 vaccine. The patient was scheduled for his second COVID-19 vaccine shot on 30Mar2021.  Information on the batch/lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Bullous pemphigoid cannot be excluded.  The case will be reassessed if additional information becomes available.  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 adverse events. 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.
Sudden onset of blurry vision, frequent thirst and urination, waited 5 days to call the doctor he then had me come in and ran glucose urine test, diagnosed with type 1 diabetes due to the positive results of auto antibodies.
pt recv vax orally AM pt was fussy & had fever (not taken);pt was crying but comfortable;T101, screaming & stiffening;T103 R, screaming stopped @ 2PM;refused bottle of anything;
Information has been received from a registered nurse concerning a 35 month old male with no past medical history who on 6/30/03 was vaccinated with varicella virus vaccine live. There was no illness at the time of vaccination. It was reported on 6/2/04 that the patient presented with chicken pox breakthrough yesterday. The patient had a new rash eruptions on face and arms, and crops of pimple-like itchy vesicles. The patient reportedly had diarrhea, loss of appetite and fever three days prior. The patient was treated with colloidal oatmeal and diphenhydramine HCl. No product quality complaint involved. It was reported that the patient recovered. There were no relevant diagnostic tests or laboratory data. No further information is expected.
Moderna arm, heart racing, palpitation,flushing face numb side of face,   Racing heart and palpating lasting on and off.  Stomach problems. Flushing. Two hospital visits
Vaccine was stored post puncture past the recommended manufactures time (stored up to 28 days)
Patient experienced what was said to be a granuloma on the right arm. Patient was ordered doxycycline, cephalexin, and prednisone.  Patient had biopsy and was confirmed to be squamous cell carcinoma. Patient underwent surgery and is currently using Hydrocodone/APAP for pain.
Systemic: Fainting/Unresponsive-Medium, Systemic: Seizure-Medium, Systemic: Vomiting-Mild, Additional Details: Approximately 5 minutes after 0.5mL Moderna was given, patient's pupils fully dilated and arm muscles rigid. She came to but did not know where she was. EMS called; patient declined to be taken to hospital.
red raised macular rash abd arms, face & no other sx;dec appetite APAP given;
vaccination site pain; Chills; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "vaccination site pain"; CHILLS (non-serious), outcome "recovered" (2022), described as "Chills"; FATIGUE (non-serious), outcome "recovered" (2022), described as "Fatigue".  Additional information: The patient's height and weight were not reported. On an unspecified date, patient had significant side effects. Patient had fatigue and chills for day and fatigue for three (both events with dose number series 2). Patient had never had significant side effects from a vaccine before. Causality for events Fatigue and Chills  as per reporter (Drug/Vaccine) and Mfr was Possible.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
headache; Developed injection arm soreness after receiving Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and VACCINATION SITE PAIN (Developed injection arm soreness after receiving Moderna vaccine) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and VACCINATION SITE PAIN (Developed injection arm soreness after receiving Moderna vaccine). At the time of the report, HEADACHE (headache) and VACCINATION SITE PAIN (Developed injection arm soreness after receiving Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-089696, US-MODERNATX, INC.-MOD-2021-089717 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089696:Crosse linked
Pt developed severe hypotension and two episodes of syncope at onset of hypotension.  Since that date we have struggled to maintain her blood pressure over a systolic of 100.  She frequently runs 75/55 sitting down.  She is not orthostatic.  Resting P has increased from 80 to 95.  She is currently taking Droxidopa 400mg tid prn and Midodrine 10mg prn.  Additionally, when these do not raise her systolic to 100, she takes 100 Hydrocortisone.  The presumed diagnosis is dysautonomia, and she has been referred to a specialty center.