chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling, redness, and heat still occurring a week after injection.  Slight itch. All slightly below injection site
0951 Pt c/o sensation of throat tightening.  Pt remained A&O x 4 skin pink warm and dry, ventllating well, speaking in full sentences and managing secretions well. No swelling of tongue, lips or uvula observed.   patient accompanied to ED but left prior to be seen
NauseaVomiting, Swollen and painful right Deltoid, chills, jittery  Narrative:
Pt came on 4/9/2021 presenting c/ogeneralized fine pinpointed red rash (petechial), except on face since Tuesday 4/6/21, states that she gother first Pfizer COVID-19 vaccine on 4/5/2021.    No itching. Patient had CBC, rapid strep, urine HCG, and COMP metabolic completed during clinic visit on 4/9/2021with results shown below including platelet count reported at 38.  Labs ordered to be completed as sendout and pending results are  RPR Dx w/Reflex - OS,    PT w/Inr  - OS,  PTT, Activated - OS,Hemoglobin A1C - OS,    CBC (includes Diff/Plt)-OS  .    Pt referred to ER for further evaluation.
While waiting in line to pay for vaccines, patient stated he felt "hot" and "lightheaded" Pt appeared to be pale and shaking. Brought to exam room BP=110/80, R=28, P=88, Lying down, Rescue called O2 Sat. on RA 100% Client taken by rescue squad to ambulance. Client rested in ambulance and was not transported to hospital. Returned to pay for vaccines.
patient did not receive the full second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (patient did not receive the full second dose) 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 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 19-Apr-2021, the patient experienced ACCIDENTAL UNDERDOSE (patient did not receive the full second dose). On 19-Apr-2021, ACCIDENTAL UNDERDOSE (patient did not receive the full second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Nurse reported that an unknown amount of the vaccine went down the patient's arm and was concerned that the patient did not receive the full second dose  Products known to have been used by the patient, within two weeks prior to the event were not provided.  No laboratory investigations were provided. The Treatment information was not provided.
A report has been received from a Health Professional concerning a 12 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The patient experienced administered expired FLUMIST QUADRIVALENT which started on 26-Nov-2014. The outcome of the event of administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Breakthrough case admission after 5 vaccines Moderna 2/9/21 lot# 032H20A;  Moderna 3/9/21 Lot# 011M20A;  MOdern 8/27/21 lot# 017E21A;  Pfizer 3/22/22 lot# FJ4991;  PFizer 9/15/22 lot# GJ5342
"Pfizer-BioNtech COVID-19 Vaccine EUA" 1st vaccine dose received on 12/29/2020, 2nd dose received on 1/19/2021. On 2/1 SARS COV-2 IgG Semi Quantative assay showed strong positive result for COVID 19 antibodies. On 3/25/2021 night developed  sore throat, cough and body aches. On 3/26 took PCR Covid-19 test at Urgent Care Center. On 3/27 received positive COVID 19 test results. As of 3/27 and 3/28 developed COVID symptoms (sore throat, congestion, loss of smell and taste,  body ache, headache, chills).
Patient had nausea, fatigue and generalized malaise 48 hours after vaccination and was given an exemption
Inappropriate schedule of product administration; patient tested positive for covid19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (patient tested positive for covid19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration) 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 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced COVID-19 (patient tested positive for covid19). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration). At the time of the report, COVID-19 (patient tested positive for covid19) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, SARS-CoV-2 test: positive (Positive) tested positive for covid19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment was reported. Patient wants to know if she can take the second dose of the vaccine.
pt says she developed chills and fatigue.  She is weak and has a rash around her ears and her neck that goes down her back.  She has itching and redness around the injection site.  Her symptoms are getting worse instead of better so she will contact her PCP.  She is using Neosporin and alcohol.
Information has been received from a physician concerning an infant who was vaccinated with the third dose (completed series) of ROTATEQ after the age of 12 months. No symptoms were reported. There was no product quality complaint. Additional information has been requested.
Acute kidney failure, unspecified GROIN SWELLING DIFFICULTY URINATING WEAKNESS - GENERALIZED
Patient age 17 was vaccinated on 04/06/2021 at 2:45pm with Moderna vaccine. Patient at the time was under the recommended age by Moderna to receive the vaccine.
6:30 PM felt chills, aches, headache throughout night-chills. Several bouts diarrhea Wed and Thurs, missed 1 day work.
The date of symptom onset is an approximation since the mother did not remember the exact date of symptom onset. Few weeks after (September 2021) receiving the 2nd dose of the COVID-19 vaccine (August 2021), the patient started complaining of left foot pain and swelling. She was evaluated by different providers (including orthopedics and podiatry) and the cause of her symptoms remained unknown and ongoing. On 4/7/2022, she was evaluated by pediatric rheumatology.  On exam she was found to have arthritis of her left ankle and midfoot, as well as she had signs of arthritis of her right elbow and right index finger.  The patient was diagnosed with polyarticular juvenile idiopathic arthritis and was started on methotrexate and steroids with partial response; etanercept therapy was requested by her insurance company but it was denied and multiple appeals were filed the results of which are still pending.
muscle pain in arm and back; Soreness/Tenderness in arm as expected; Headache; fever; chills; This is a spontaneous report from a contactable consumer (patient herself). A 23-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL3248), via an unspecified route of administration on the left arm, on 02Feb2021 08:15 at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Feb2021 20:00, the patient experienced soreness/tenderness in arm as expected. At around 8pm (12 hours after injection), patient started feeling muscle pain in arm and back. About an hour later, patient started to run a fever and had chills. Headache came on after and lasted through the night and into the next morning. Since the vaccination, the patient has not  been tested for COVID-19. The outcome of the event was recovered on an unspecified date. Case was reported as non-serious.
UNSTABLE ANGINA STABLE ANGINA 10/17/2022 -- RECURRENCE OF SAME SYMPTOMS
it was rpt fr pharmD concerning pt who was vax & subsequently exp an anaphylactoid react. no further info avail
This case was reported by a healthcare professional (nurse) and described the occurrence of possible allergic reaction in a female subject of unspecified age who was vaccinated with DTPa (manufacturer unspecified). Concurrent medical conditions included allergy to tetanus vaccine. The subject reported that she had an "allergic reaction to a Tetanus shot as an infant". On an unspecified date the subject received unspecified dose of DTPa (unknown). At an unspecified time after vaccination with DTPa, the subject experienced possible allergic reaction, rash and difficulty breathing. The healthcare professional called to inquire about possible allergic reaction to Dtap if a subject had an allergic reaction as an infant. It was not confirmed that the vaccine that caused the reaction was a Dtap as the subject told the nurse it was a Tdap, but the nurse was questioning it because the Tdap "came out in 2005" and the subject would not have been an infant at that time as she was college student at the time of the report. The nurse thought it may have been Dtap. The subject also reported that she had an allergic reaction to a Tetanus shot as an infant. No further detail was provided. At the time of reporting the outcome of the events was unspecified.
Approximately, 6 hours after vaccine: Temperature 102, Chills, all over body muscle aches, joint pain, bad headache, sinus pain, fatigue, short of breath. Took 500mg Tylenol every 4 hours. Second day:  same symptoms less severe & temperature down to 100. Still taking 500 mg Tylenol every 4 hours 3rd day: fatigue, short of breath on exertion, mild headache, mild muscle aches. Tylenol taken at night.
Postive covid 19 test post vaccine. Patient is asymptomatic with this positive test done for a pre procedural screen,  had COVID in Dec 2020 and was symptomatic then.
skin was lighter in color; it was really rough; lose; itches; Rash; pain; swollen lymph nodes; This is a spontaneous report from a contactable consumer and contactable other health professional.  A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration at arm left on 11Jan2021 at 11:30 at single dose for COVID-19 immunization. The patient medical history included rheumatoid arthritis, coronary artery disease, both from an unknown date and unknown and COVID-19 from Mar2020 to an unknown date.  There were no concomitant medications.  The patient previously took flu vaccine and pneumococcal vaccine and for both experienced sickness, chills and "couldn't eat". The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunization and experienced swollen lymph nodes. The patient experienced swollen lymph nodes on 12Jan2021, the rash was first noticed on 13Jan2021 and started on the right under arm (the opposite side she got the shot), there was pain. On 15Jan2021 it moved to the left side. The right side was starting to get better though her skin was lighter in color. The left side was about the same, it was really rough, lose and itches. It looks like elephant skin. Therapeutic measures were taken as result of events and included topic treatment with MINERIN CREAM (therapeutic moisturizer). The patient outcome of swollen lymph nodes was recovered (within 2 days), the outcome of rash and related events was not recovered.
pt recv vax 7APR98 sz began 17APR98 w/fever 103;pt taken to local ER;pt dx w/possible PNX given ATB;ER MD stated sz caused by fever;dx as viral PNX;pt released from hosp same day;
Pt. received a Tdap in (R) and MENACTRA in (L) mom called 4-30-14 stating the (L) arm was swollen up to the size of baseball, red and itchy the Tdap was also swollen mom advised to go to urgent med to have it looked at.
Same low grade fever, had fever for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Same low grade fever, had fever for a couple of days) 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 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 PYREXIA (Same low grade fever, had fever for a couple of days). At the time of the report, PYREXIA (Same low grade fever, had fever for a couple of days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was provided.  No treatment medication was provided.    Most recent FOLLOW-UP information incorporated above includes: On 20-Aug-2021: Included reporter details, narrative details
Chills, fever, headache, face pain, coughing, body aches, Methylprednisolone and Bromphen/Pseudo/Dextro HBR Syrup.
nausea, diarrhea, 102 degree fever with chills, slight headache
Fibromyalgia; extremely tired; Slept almost all day; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FIBROMYALGIA (Fibromyalgia), HYPERSOMNIA (Slept almost all day) and FATIGUE (extremely tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included DUPILUMAB from 04-Mar-2021 to an unknown date for Asthma.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERSOMNIA (Slept almost all day). On an unknown date, the patient experienced FIBROMYALGIA (Fibromyalgia) and FATIGUE (extremely tired). At the time of the report, FIBROMYALGIA (Fibromyalgia), HYPERSOMNIA (Slept almost all day) and FATIGUE (extremely tired) had not resolved.            Concomitant medications also included unspecified steroids.  Patient reported that she experiences fatigue and hypersomnia every time she gets her dupilumab dose.  No treatment medications were reported.
COVID 19 Treatment; COVID 19 Treatment; Patient received Moderna vaccine for Dose 1 and 2 and Pfizer vaccine for Dose 3, 4, and 5; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Nov2022 at 12:30 as DOSE 5 (BOOSTER), SINGLE (lot number: GH9693) at the age of 61 years old, administered in the left arm for COVID-19 immunization; BNT162b2 (BNT162B2), on 16Jul2022 as DOSE 4 (BOOSTER), SINGLE (lot number: FP7135), administered in the left arm for COVID-19 immunization; BNT162b2 (BNT162B2), on 12Dec2021 as DOSE 3 (BOOSTER), SINGLE (lot number: 33030BD), administered in the right arm for COVID-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 11Jan2021 as DOSE 1, SINGLE (lot number: O12L20A), administered in the left arm and on 08Feb2021 as DOSE 2, SINGLE (lot number: O29L20A), administered in the left arm for COVID-19 immunization. The patient's relevant medical history included: "allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Dec2021, outcome "unknown" described as "Patient received Moderna vaccine for Dose 1 and 2 and Pfizer vaccine for Dose 3, 4, and 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment." The patient underwent the following laboratory tests and procedures: COVID-19 test (SARS-CoV-2 test): (Feb2023) Positive, notes: COVID-19 Treatment. Therapeutic measures were taken as a result of Drug ineffective, Covid-19.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient was vaccinated with a dose of ZOSTAVAX on 20-SEP-2012. (Lot number reported as 1506Z and Expiration date as 02-FEB-2012). Concomitant medications were not reported. The reporter stated that the patient received ZOSTAVAX on 20-SEP-2012 that had expired on 02-FEB-2012. No adverse effect was reported. Additional information has been requested.
Spontaneous abortion/miscarriage in June 2021. Subsequent pregnancy with chromosomal abnormality Trisomy 21 in September 2021.
Abnormally heavy and long menstruation resulting in iron-deficient anemia, lasting 2 weeks, with abnormally painful cramps. Episodes of fainting, nausea, diarrhea, and vomiting. Smell hallucinations, muscle soreness, brain fog.
Patient received the above Pfizer for a second dose but it should have been a Moderna.  1st Moderna was given 8-12-21 lot # 047C21A
Menstrual cycle is the worst it?s ever been. Extreme blood clots, headaches, severe cramps. Bleeding through tampons every 2 hours.
Local reaction with pruritus and erythema. Cool compresses, antihistamine, hydrocortisone cream.
sz (w/t103) & bronchitis by CXR), 1 day p/vax
Patient was administered the injections and asked to wait in the store for a few minutes before going home to ensure she was feeling alright. The patient went to walk around the store and stopped to speak to her daughter and was standing at the side of a shopping cart. The patient went to walk away from the spot and fell. The patient never lost consciousness but was unsure of the reason why she fell. The patient denied any syncope but did report that she "just didn't feel right". The pharmacist measured the patient's blood pressure which was 118/78 mmHg which the patient reported was normal range for her. The patient was further monitored in the store with no additional episodes and was taken home by her daughter. The pharmacist called the patient at 2:35 pm and the patient reported that she was sore from the fall but denied any further episodes of falling or feeling different. The pharmacist notified the patient's PCP of the patient's fall.
I'm still getting pain in my arm where I got the vaccine.  It doesn't hurt to the touch, the pain is internally in the arm at the site of the injection.  It continuously comes and goes since the day I received it.
Adverse Event: Guest checked in and was screened according to protocol and denied receiving any injections within the last 14 days. When guest was checking out, it was discovered that he had received the Pfizer Vaccine on 4/29/2021 (Lot #ER8729) - Left Deltoid.   Treatment: Guest assessed for adverse side effects - none observed. On-Call medical provider notified - advised to schedule guest for their second dose according to vaccine schedule. Guest educated on the risks and benefits of his actions and instructed to go the the nearest emergency room if he experienced  any untoward events. Outcome: Guest educated. No adverse side effects observed or reported.  Guest scheduled for second dose according to Pfizer Vaccine Schedule. Guest encouraged to report this event to his primary care provider.
Fevers to 104 degrees with delerium, severe muscle contractures of neck, upper back, and left arm. Severe rigors. Involuntary spasms of back and neck lasting 1-3 minutes. Severe headache -frontal location and behind eyes. Possible febrile seizures per husband  (temp 104.5, not responsive, repeated jerking of neck- resolved after placing in ice bath) . Fevers refractory to ibuprofen/tylenol. Initially continued for duration of 12 hours, remitted for 2 hours, then resumed for additional 24 hours. Intermittent muscle spasms with chills continued for another 12 hours, along with muscle soreness.
On 05/03/2002, the pt was diagnosed with ear infection , runny nose and on antibiotic for 10 days. On 05/15/2002, the pt broke out in fine red rash on trunk and more intense around he mouth and left leg. No fever. The pt was told to wait and see and return if condition worsens. On 05/22/2002, the pt's symptoms resolved.
Pt recvd 1st dose of Engerix-B on 06MAY91 & 4 hrs later exp generalized rash which lasted about 2 hrs; Resolved w/o tx;
BUD for vaccine: 12/18/2021. Vaccine administered 12/19/2021. Expiration date on vial: 02/2022.
Drug eruption - Localized reaction to Pneumococcal injection 2 days ago. Redness 6cmx7cm eruption, with swelling, redness, & mild itching. Pt given Hydrocortisone cream 1%, 250mg SOLU-MEDROL 250mg injection, BENADRYL 50mg injection, & BENADRYL 25mg PO q 6hrs.
Local reaction left upper arm 3x3 cm erythema with increased heat, tender, pruritus, slight swelling.
Student with symptoms of nausea, skin cold with pallor in lips and face area. Red patches to neck  posterior and anterior and upper arms. S/S started within 10 minutes of administration. V/S taken and noted. B/P 90/60. Student was assisted to lying position withlegs elevated. BENADRYL 25 mg IM to Rt. Deltoid administered at 11:35 am. By 11:50 am student verbalized feeling better no nausea reported and skin patches were noticeable to neck anterior in light pink color. No visible skin marks noted to upper arms, face or posterior neck.
The night of the vaccine I spiked a fever of 103.0 that lasted 3 days along with chills, vomiting and body aches. On May 10th I started having problems breathing, I was having coughing fits, trouble getting air and was brought to the emergency room on on May 11th. They did chest xrays, have me albuterol treatments and steroids and sent me home. I tried to go to work on May 13th ( I work at a doctors office) and I was immediately sent to the hospital as I went into respiratory distress with my oxygen levels in the low 80's. I was given more steroids, IV steroids and sent home with an inhaler. I went to my primary care physician for a follow up on May 17th  I was still having trouble breathing, was given 2 breathing treatments at the doctors office and then they called an ambulance for me to take me to the hospital for respiratory distress. I was admitted to the hospital for 4 days where I was given 2 IVs, more chest x-rays, a CT, I.V. steroids, epinephrine,  and breathing treatments every 3-4 hours or as needed. At one point they considered intubating me to let my lungs rest as I could not breathe and would cough until I vomited. No one could figure out the cause and assume it was a vaccine reaction. I was then sent home with at home Duo nebulizer treatments, inhaled steroids, and cough syrup. I also had a lung function test done.
I spent 17 days in country (May1-17) and then three and a half days in country.  I tested negative on Friday, May 20 at 2:30PM in country, the country so I was able to board my plane to return home, and awoke at 3:30AM on Sunday, May 23 in my bed barely able to move my body and with significant asthma.  I tested positive on an at-home antigen test and on a PCR test at a testing center.  My doctor put me on Paxlovid for five days and I was mostly symptom free until the Paxlovid ended (May 27, 2022).  Since then, I have had asthma and laryngitis, despite being on inhaled steroids since May 24, 2022.  And, I'm still testing positive on at-home antigen tests..