chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He got his 2nd vaccine, about 2 hours later he had a bump on the back of his neck and a small rash.  From the pamphlet he received said that was normal.  he started to feel tired as the day went on.  By the evening his arm was doubled in size around the injection site, he was hot, painful and his joints were starting to hurt.  It wasn't until later in the evening where he was looking over the notes of what was said about the vaccine and decided something was wrong.  He started to feel disoriented and scratchy throat.  He was so disoriented he could not remember where his EPI pen was as he is allergic to bees (anaphylactic).  He called a friend to pick him up, they had stopped to get Benadryl and he called 9-1-1.  He first talked to a dispatcher and they sent him to the fire department who transferred him to poison control was on hold and contacted the hospital and about an hour he was admitted into the ER, which is down the road from where he lives, and treated for the allergic reaction.   The states knowledge about this vaccine was very limited and they bounced him around to get some assistance.  They thought he had monkey pox and not a reaction to vaccine.   He was given 60 mg of Prednisone, even though he had taken 25 mg of Benadryl and gave him 50 mg of Benadryl and some Famotidine.  They did an EKG that was normal, COVID test was negative, strep test was negative as his throat was red.  The redness started to go down around the injection site and then released about 3:00-4:00 AM on Friday morning.    They sent him home to be on 60 mg of Prednisone and the Benadryl as needed, to take every 4 hours as needed.  From Friday to Sunday morning he woke up with different symptpoms of rash on his feet, rash at the injection site ,and was taking the Prednisone.  Sunday morning he woke up with headache, didn't have the rash on his feet, but did have a large rash around the injection site.  he also was feeling the joint pain again and went back to the ER with low back pain, tightness in his chest, chest pain, light headed and headache.  During that time they admitted him to the ER, they ran a full 12 lead EKG, they did a lot of different blood tests, urinalysis, blood test from his heart.  Blood work showed some dehydration, extremely high WBC in which they did administer fluids, put in a catheter.  He was pretty anxious so they gave him Ativan and with the lower back pain they gave him a non-noncardiac anti-inflammatory and diagnosed with a UTI secondary to the allergic reaction to the vaccine.   He was given a large dose of Cephalosporin, finished the prednisone yesterday and is taking an allergy pill in the morning Loratadine, and takes 1500 mg a day of Keflex.    His first vaccine was given IM in the back of his arm and he did not have any reaction to that.    He is a transgender female/male with transformation 13 years ago, and is on Testosterone injections weekly.
A report has been received from a Health Professional concerning a 49 year old, female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 20-JAN-2015. It was reported that three patients received expired FLUMIST Quadrivalent on 20-JAN-2016 which was expired on 05-JAN-2015. The outcome of the event of three patients received expired FLUMIST Quadrivalent is unknown. The report was considered to be non-serious.
Patient was was brought to the ED from facility which  he received the vaccine via ambulance with BiPAP, hypoxia, and one dose of Epi of 0.3 mg. He then required intubation, and had struggled with hypoxia, even on increasing PEEP. CODE BLUE called in the ED for PEA. He was medicated for such (please see the code run sheet for details), and he came in and out of the code 5 times. After 95 minutes, with the wife at the bedside, and family conference by phone, the code was called, and he was pronounced at 18:20. He received in total 8 me of Epi, 3 shots of Atropine, 3 amps bicarb. He got lasix 40 mg, lovenox 60 mg subcutaneous once. He had a CVC into the right internal jugular, and levophed was started, then Epinephrine drip was started.  Prior to the code he got steroids (solumedrol 125 mg, then later decadron 6 mg iv), benadryl iv, antibiotics (ceftraixone / zithromax), and lasix 40 mg. All this time while in the ED, the Rt was at the bedside, and lots of secretions from the lungs were aspirated, bloody color.   Code was the result of PEA secondary to hypoxia (</= 85%), despite being on the vent, with PEEP 12, FiO2 of 100%, with acidosis.   After 95 minutes of active resuscitation, the patient was found not responsive to painful stimuli. There was no palpable pulse. No spontaneous respirations. No heart or breath sounds by auscultation. Absence of pupillary light reflex.
Itchy red area measuring approximately 5inches long by 4 inches wide with darker red area in the center approximately 2 inches below injection site. Started 9 days after vaccine. 1st day area was approx 3 inches long by2 inches wide. By evening it had gotten larger, next day more red and itchy and larger. 3rd morning same size but red color is not as bright and no itch.
I was getting eczema on the inside of my elbows after the booster. The eczema was on the right and left arm. It was uncomfortable enough to see the dermatologist. I had to have cream prescribed. I never had this before having the COVID-19 booster. I did try over the counter medication like hydrocortisone cream that was effective. I only use Triamcinolone as needed. It took 5-7 days to clear up the symptoms. The symptoms come and go, and I use the medication when they break out again. It appears that its not going to be gone forever as it continues to come back.
Headache, Sedation, Myalgia, Arthralgia, Fever,  Chills, injection site pain  Narrative: After 1st dose on 2/12/21 noted a euphoric feeling x 4 hours, then extreme then extreme fatigue and myalgias for 5 days. Left arm was very sore for 5 days at site and red and swollen. Had pain in neck and head for 3 days. Finally felt baseline at 5 days. After 2nd dose on 3/12/21 noted site pain within 5 hours, still had some disconnected feeling but less than last time. Next day had increased arthralgia. On 3/14/21  had fatigue and developed headache that afternoon. Fatigue worsened as day went on. Headache worsened that night. On 3/15/21 still  had bad headache and fever/chills. The headache finally lessened by the evening of 3/15/21. Missed work x 1 day. No known prior COVID infection.
Shortness of breath.  Diagnosis is A-fibrillation, heart failure, put on Entresto medication.
Minor arm pain.  Aches started in jaw followed by headache and fever.  Significant fatigue.  Lasted about 22 hours.
Covid breaththrough case/ she was tested positive with a Covid breakthrough case; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid breaththrough case/ she was tested positive with a Covid breakthrough case) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, the patient experienced COVID-19 (Covid breaththrough case/ she was tested positive with a Covid breakthrough case). At the time of the report, COVID-19 (Covid breaththrough case/ she was tested positive with a Covid breakthrough case) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Oct-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant products were reported. Patient reported that on 06-Oct-2021 she was treated with one time infusion of monoclonal antibodies. And states she was fine since the infusion.  Company comment: This is a Spontaneous case concerning a female patient of unknown age with unknown medical history,  who experienced the unexpected  non serious (AESI) event of COVID 19. The event occurred approximately 8 months after the second dose of mRNA 1273 vaccine. Exact latency between doses is unknown.  Patient was treated with monoclonal antibodies and has been stable.  The rechallenge is not applicable.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a female patient of unknown age with unknown medical history,  who experienced the unexpected non serious (AESI) event of COVID 19. The event occurred approximately 8 months after the second dose of mRNA 1273 vaccine. Exact latency between doses is unknown.  Patient was treated with monoclonal antibodies and has been stable.  The rechallenge is not applicable.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
After receiving Moderna vaccine in left arm, client passed out in chair, and fell to the floor.  He was aroused with the assistance of  staff.   Client presented  diaphoretic and extremely anxious.  Emergency Services were notified, and arrived, client's vitals were 120/80, 68 (sitting), and 120/80, 62 (standing), blood sugar was 112.  Client denied any medical problems, but admitted he  had similar episode when receiving a steroid shot for an injury in a doctor's office.   Client stated he always gets extremely anxious and blacks
When I received the shot it hurt so bad. I had deep pain. He gave me the shot very high next to my shoulder. It has been three weeks and it is no better. Went to Dr's. He said he gave it to me in my bursae.
On 11/09/2001 the patient noticed 2" red, warm patches on her right arm about 6-8" away from the injection site, on the medial aspect of her arm. The patient denied itchiness, swelling or any symptoms at the injection site. The redness resolved by 11/11/2001.
immediate numbness at injection site, metallic taste in mouth that still hasn't gone away, numb mouth, eyes and sinuses. Dizzy.
No adverse effect; patient was administered his first dose of GARDASIL 9 around 24-OCT-2018 and had just received the second dose on 24-APR-2019; This spontaneous report was received from a pharmacist, referring to a male patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions and concomitant medications.  On 24-OCT-2018, the patient was vaccinate with his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscularly, lot# N035957 (expiration date: 10-OCT-2020) for prophylaxis (strength and frequency were not reported). Then on 24-APR-2019, the patient received a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), for prophylaxis (strength, frequency, route of administration, lot number and expiration date were not reported)(inappropriate schedule of product administration). The patient was on the three dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) schedule. No adverse effects were reported.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 9:11 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 9:38 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 49.54 for 031L20A and 49.63 for 031A21A.  No concomitant medications were reported.  Batch number 031L20A administered on 13-Feb-2021 had  temperature 32 at 09:00 AM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021.  Batch number 031A21A administered on 20-Mar-2021 had  temperature 34 at 09:00 AM and 37 at 10.00 AM. This vial was moved to fridge on 09-Mar-2021 and beyond use date for the vial was reported as 08-Apr-2021. Product moved to clinic on 20-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported   This case was linked to MOD-2022-566976 (Patient Link).
The rash that originally started with the first shot back in April (April 20, 2021) continues to plaque me.
joint pain, first in knee where I have had problems before, and now in hip which is new.  arthritic changes in knee, none shown by x ray to hip
J&J/Janssen COVID-19 Vaccine EUA Symptoms: Headache, Migraine, Nausea, Fever   Had a headache the morning of when I was going to get vaccinated. The headache went away before the appointment (did not take any medication); however the headache returned about 10 minutes after I got vaccinated. A few hours later the headache converted to a migraine resulting in increased nausea. Overnight I developed a fever. Within 24 hours, all the symptoms were gone. At this time I have fully recovered from all side effects but am monitoring my heath to see if anything else comes up.
large knot at injection point. Red and itches and swelling does not seems to be going down and a little painful. Looks somewhat like a rash. I got the shot on a Thursday night got chills and aches and pain by Friday, Saturday my symptom was better.  Had no problems with the othe two shots.  I'm having some kind of reaction because its itching like crazy.
experience a dry throat; experience a dry mouth; sore arm; This spontaneous case was reported by a patient and describes the occurrence of DRY THROAT (experience a dry throat), DRY MOUTH (experience a dry mouth) and PAIN IN EXTREMITY (sore arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jun-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2022, the patient experienced DRY THROAT (experience a dry throat), DRY MOUTH (experience a dry mouth) and PAIN IN EXTREMITY (sore arm). At the time of the report, DRY THROAT (experience a dry throat) and DRY MOUTH (experience a dry mouth) had not resolved and PAIN IN EXTREMITY (sore arm) outcome was unknown.            Concomitant medication details were not reported by the reporter. Treatment detail was not reported by the reporter.
had the shot 3-4 years ago. Last year I got shingles!/suspected vaccination failure; shingles; itching; pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pruritus and pain. On an unknown date, the outcome of the vaccination failure, shingles, pruritus and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the shot 3 to 4 years ago, last year from the date of reporting the patient got shingles. At the time of reporting the patient experiencing random itching, pain that feels just like when the patient had shingles. This case was considered as suspected vaccination failure as time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Pt reported dizziness, and fainted, woke up quickly and vomited.  Ambulance was called for.  Blood pressure was extremely low and pulse rate was high as reported by ems.  pt became more alert and did decline ambulance ride to the hospital.   spoke later to spouse and they did go to emergency room.
Covid monitoring documentation. PT admitted 12/14/21 documented to have positive covid. PT received Pfizer 5/21/21 Lot ER8736 for dose 1. Dose 2 was Pfizer given on 06/11/21 Lot ER8735. PT expired on 12/17/21 due to respiratory failure secondary to COVID pneumonia.
Red patch on neck 2x4 inches in size; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red patch on neck 2x4 inches in size) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced ERYTHEMA (Red patch on neck 2x4 inches in size). At the time of the report, ERYTHEMA (Red patch on neck 2x4 inches in size) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact
This spontaneous report as received from a pharmacist refers to a patient of unknown age (gender not reported). On 09-NOV-2012, the patient was vaccinated with an expired dose of ZOSTAVAX, 0.65ml, SQ (subcutaneously) lot # 671453/1057AA, exp. date 05-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Fever max of 103.3 within 24 hours. Numbness tingling, paresthesia in my hands and feet.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hidradenitis supprativa" (unspecified if ongoing); "psoriasis" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: BACTRIM, start date: 23Aug2022, stop date: 01Sep2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (08Sep2022) Positive, notes: Then day 5 afterward became congested again. Have been unable to get a negative test for 11 days now. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti viral details:  product: COVID 19 Treatment: Brand: Paxlovid. Treatment start date: 30Aug2022 and Treatment stop date: 03Sep2022 Indication: Treatment of COVID-19  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Felt awful, Feel crappy, Annoyed; Sweating; Flu-like symptoms; Left arm pain; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt awful, Feel crappy, Annoyed), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN IN EXTREMITY (Left arm pain) and HEADACHE (Bad headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, the patient experienced FEELING ABNORMAL (Felt awful, Feel crappy, Annoyed), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN IN EXTREMITY (Left arm pain) and HEADACHE (Bad headache). At the time of the report, FEELING ABNORMAL (Felt awful, Feel crappy, Annoyed), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN IN EXTREMITY (Left arm pain) and HEADACHE (Bad headache) outcome was unknown.            Patient reported that he had a scheduled eye injection on 21-Sep-2021 and no additional information was provided about eye injection.  Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter   This case was linked to MOD-2021-325410 (Patient Link).   Reporter did not allow further contact
S - 29 year old Male, itchy rash after first COVID-19 vaccine (rash from March  29-April 5, 2021) B - Patient calling in to report an itchy rash that developed after his first  Moderna COVID-19 vaccine. States that he had the vaccine on March 19, 2021. He experienced pain to his arm near the  injection site and then felt fine 2-3 days later. He, his wife and son stayed at a hotel on 03/28/2021. He  woke up the next morning with itchy skin and thought it was because his skin was dry and he hadn't used lotion. He  did use the hotel soap which he typically does not do as he has eczema. States that he really hasn't experienced  a flare-up in a while though. Later that day (03/29/2021),  (continued next page)
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Abdominal Pain-Mild, Additional Details: Administered Pfizer vaccine at ~01:40 PM approximately.  Patient reported mild shortness of breath and abdominal discomfort around 01:50PM.  Was able to speak, and no other major symptoms noted. Provided 2 tablets of diphenhydramine at 1PM. Monitored for 20-30 minutes. Reports improved shortness of breath, and decided to drive home.
She noticed redness, itchy swelling around the injection site, along with a sore arm and a shotty lymph node in the right axilla
2 hours post-vaccine pt. was "unable to draw breath," had rapid heartbeat. After 1 hour of this, heart rate slowed but pt reports swollen face, tongue, lips. Had 1 episode of vomiting at 7pm. Sx resolved at bedtime on their own.
pt recv vax 23OCT96 & & was noted that pt exp an ear infect @ the time of vax;10FEB98 pt devel approx 30 chickenpox which were just gen dispersed;