chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Onset of moderate to severe headache approximately 4-5 hours after receiving the second dose of an HPV vaccination. This was accompanied with mild chills and slight fever. Took regular Tylenol before sleeping that night and symptoms did not return the next day. Injection site shows redness and is both bumpy and itchy on 10/24/2012, two days after receiving the vaccine.
This spontaneous report as received from a nurse practitioner refers to a 11 years old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 22-DEC-2014, the patient was vaccinated with the dose of GARDASIL lot # K006191 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. Nurse practitioner confirmed that no adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Systemic: Fainting / Unresponsive-Mild, Additional Details: pt was seated on the chair after receiving his shot after 2 minutes he fainted-and fell off his chair he was conscious on the floor. he suffered a scraped forehead and a bruised lip we treated those sites he was bleeding from both but not a lot aqnd we stopped the bleed. Target personnel came to the scene and reported it he did not want to go to the er he left with his sister and family after 30mins and said he felt fine he said he had done this before a few years ago after receiving a shot
8 1/2 x 10 cm circular indurated erythematous region on (R) ant thigh.
Numerous satellite lesions to right deltoid region and right shoulder.  Numerous satellite lesions on back, scattered lesions on chest, and behind left ear.  Macular papular rash on chest and back.  Pale and lethargic.  Sent to ED for evaluation.
Shingles on the left side of their face; Cyst on the left side of their neck; Cyst was big and tender and ended up being removed; This spontaneous case was reported by an other health care professional and describes the occurrence of HERPES ZOSTER (Shingles on the left side of their face), CYST (Cyst on the left side of their neck) and TENDERNESS (Cyst was big and tender and ended up being removed) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), CELECOXIB (CELEXA [CELECOXIB]), WARFARIN SODIUM (COUMADIN), OMEPRAZOLE and LEVOTHYROXINE for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced HERPES ZOSTER (Shingles on the left side of their face), CYST (Cyst on the left side of their neck) and TENDERNESS (Cyst was big and tender and ended up being removed). The patient was treated with ACYCLOVIR [ACICLOVIR] for Shingles, at an unspecified dose and frequency and Surgery for Cyst. In 2021, CYST (Cyst on the left side of their neck) and TENDERNESS (Cyst was big and tender and ended up being removed) had resolved. At the time of the report, HERPES ZOSTER (Shingles on the left side of their face) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The consumer stated that she had shingles on the left side of their face and a cyst on the left side of their neck, starting a couple of weeks after the first dose. The consumer stated that the cyst was big and tender and ended up being removed. The  provider seemed worried about the caller having spiked proteins.     This case was linked to MOD-2021-302081 (Patient Link).
Safety and Immunogenicity of Fluzone Influenza virus vaccine (2005-2006 formulation) among healthy children 6 to 12 weeks of age. Initial report received on 30Sep05 from an investigator participating in the above mentioned trial. A two month old female subject developed generalized hives/urticaria and a left swollen ear and was diagnosed with an allergic reaction 10 to 20 minutes after receiving an IM injection of Fluzone No preservative 2005-2006, lot number UD07402, or Placebo in the right thigh on 30Sep05. The subject had no reported medical history. She was treated with Benadryl and Tylenol per os. Her oxygen saturation level was 97% to 98%. The pt recovered from the events. Documents held by sender: physician's office note.
During a school based clinic, this child was given H1N1 nasal mist without parental consent. He stepped up to claim the consent when another child's name was called. The other child had the same last name in the same classroom. The child who mistakenly received the dose had a history of asthma.
Fever Pain & swellin of R. shoulder Pain on neck Swelling (L) eyelids
first dose of shingrix was administered 3 years ago; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose was administered 3 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: first dose of shingrix was administered 3 years ago). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date - 19-OCT-2023 It was unaware if the patient received 2nd dose or not, which led to incomplete course of vaccination.
Patient reported large bruise on left arm at site of vaccination. Bruise was 3in in diameter. Patient also reports mild discomfort in left arm. These occurred within 24 hours of vaccination.
C/O pain with muscular tightness from shoulder to wrist area & headache.  Symptoms continue throughout today, 10/29/2015. Client did not go to doctor for medical treatment.  Returned to health department.  RN assessed client.  No edema noted in arm.  Minimal redness with mild warmth at injection site.  Arm painful to touch.
DISORIENTED; COULD NOT EVEN WALK; LOSS OF APPETITE; NO STRENGTH; WEAK LEGS; FEVER; HEADACHE; FATIGUE/EXHAUSTED/TIRED IN LEGS; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043AZIA, and batch number: 043AZIA) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced disoriented. On 04-APR-2021, the subject experienced could not even walk. On 04-APR-2021, the subject experienced loss of appetite. On 04-APR-2021, the subject experienced no strength. On 04-APR-2021, the subject experienced weak legs. On 04-APR-2021, the subject experienced fever. On 04-APR-2021, the subject experienced headache. On 04-APR-2021, the subject experienced fatigue/exhausted/tired in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on APR-2021, had not recovered from weak legs, no strength, headache, fatigue/exhausted/tired in legs, disoriented, and loss of appetite, and the outcome of could not even walk was not reported. This report was non-serious.
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Additional Details: Pt experienced a brief syncope episode.  Nurse, the immunizer, was there with her and her mother the entire time. We observed pt for over 30minutes and they left the pharmacy with no other symptoms.  I called pt the next morning and she stated that fainting was a \"normal reaction...I get it everytime I get a shot\".  She is in between doctors right now and does not feel like we need to contact him.  Will talk to her new doctor next time she is seen
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. Information on concurrent condition and medical history was not reported. On unspecified dates of 2005, the patient received two doses GARDASIL (dose, route and lot number not reported). The reporting nurse stated that the patient did not receive her second dose on time according to the recommended dosing schedule. The nurse practitioner stated she did not know if the patient ever received a third dose. No adverse symptoms reported. No further information provided. Additional information is not expected as the reporter did not have any further details to provide and did not with further contact.
FLU LIKE SYMPTOMS STARTED 3AM 1/29/2021 WITH GENERALIZED BODYACHE, LEFT AXILLARY PAIN, TENDER LEFT CERVICAL NODES, HOT AND COLD FLASHES AND HEADACHE. NASAL CONGESTION.
Hives and itching  10 minute  onset at site of injection, spread to hold arm then to body only after 15 minutes.
No additional AE; vaccine was given after temperature excursion; This spontaneous report was received from a nurse and refers to a 6-year-old female patient.  The patient's medical history, concurrent conditions , concomitant therapies and previous drugs reactions or allergies were not reported.  On 16-JAN-2023, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX)  lot #W008711, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided); diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided); and  hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided)following a temperature excursion of -10.5 degrees Celsius for 1hour 34 minutes (product storage error). It was stated that a data logger was involved and no previous temperature excursion occurred. No adverse reaction reported.  This is one from several cases from the same reporter.
Exp date Vaccines went into 2-8 C thaw state on or about 20-Dec-2021; Received its 30-days Exp date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date) and PRODUCT STORAGE ERROR (Exp date Vaccines went into 2-8 C thaw state on or about 20-Dec-2021) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     It was unknown if patient had acute illnesses and chronic and long standing health conditions.     On 31-Jan-2022 at 11:59 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Jan-2022 at 11:59 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Exp date Vaccines went into 2-8 C thaw state on or about 20-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date) and PRODUCT STORAGE ERROR (Exp date Vaccines went into 2-8 C thaw state on or about 20-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  This vaccine was administered up until its Mfg Exp date of 04-Apr-2022.  No treatment information was reported.
Pfizer-BioNTech COVID-19 Vaccine EUA: presents with acute hypoxic respiratory insufficiency secondary to COVID-19 pneumonia. Received antimicrobials, oxygen, remdesivir, and dexamethasone. Discharged medically stable.
Receiving a Moderna COVID Booster and is breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Receiving a Moderna COVID Booster and is breastfeeding) in a 38-year-old female 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Receiving a Moderna COVID Booster and is breastfeeding). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Receiving a Moderna COVID Booster and is breastfeeding) had resolved. Not Provided          No Concomitant and treatment medications were reported.
Extremely itchy rash on neck from chest to chin and on facial cheeks.; scratching raised blood to the surface. This reaction continues today.; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine at Doctor's office/urgent care, via an unspecified route of administration, administered in left arm on 26Mar2021 17:00, at 56 years of age, (Batch/Lot Number: EP6955) as single dose for COVID-19 immunization. Relevant medical history included seasonal allergies. The patient wasn't diagnosed with COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medication included fluticasone taken for seasonal allergies, start and stop date were not reported. On 27Mar2021 at 06:30 the patient experienced extremely itchy rash on neck from chest to chin and on facial cheeks. It appears during showers and dissipates within 15 minutes of getting out of shower. No change in shampoo, soap, shave soap or razors. The first time the patient could not satisfy the itch and scratching raised blood to the surface. The patient didn't receive any treatment for the event. At the time of the report the events had not resolved yet.
Red rash at injection site, extreme itchiness and discomfort under skin that didn't resolve after topical hydrocortisone.
Sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore shoulder) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Sore shoulder). At the time of the report, ARTHRALGIA (Sore shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medications were reported. No treatment related information has been reported.     This case was linked to MOD21-041442 (Patient Link).   Reporter did not allow further contact
Open mouth yawn "tic" lasting anywhere from 10-20 seconds about 30 times an hour. Over the course of 2 week, duration has lessened to 1-5 seconds and frequency lessened to 1-4 times an hour. After a month it is only noticed a couple times a month for short frequencies.
Fever to 103 within 24 hrs, chills, myalgias, diarrhea, 5x gradual improvements over next 48 hrs, then fever worsened with vomiting  St x 2 more days (6/25 and 6/26).
Body (arms, shoulders, sides, back) aches and headache, as well as occasional odd discomfort in left side of chest, that started during the late evening of 10/14/21 and continued until the early morning of 10/16/21.  Occasional mild cough that began after the aches (if i remember correctly) and continues to this day (10/26/21).  I had a COVId infection in August 2021 (positive PCR test on 8/17/21).  Based on my reaction to the first shot and studies indicating strong immune response to the first shot for previously infected people, Dr. recommended that I be considered for exemption to my employer's mandate requiring 2 shots.
Right ear was plugged upon waking 7AM. Ringing in right ear started at 12:45 PM.
She had a really bad bloody nose this morning around 9:30 am for about 45 minutes. The nurse from her school helped her to stop it but it was pretty bad. This is very unusual for her and the amount of blood was not like a typical bloody nose. It was all over her the front of her sweatshirt.
Pt states that they noticed a shingles lesion on their right thigh above the knee 2 days after receiving the vaccine. The rash spread to the groin and outter thigh before the patient went to see the doctor. The pt states they were treated with a 7 day course of an unknown antiviral medication which did not resolve the rash. The rash continued for a total of 4 weeks. Pt states they experienced severe pain throughout the time the rash was present.
Patient presents with redness, warmth and increased swelling in (R) deltoid after influenza vaccination on 10/4/2016. She reports increased discomfort in last 24 hours. Patient has been taking BENADRYL and CLARITIN daily. Mild increased discomfort with direct pressure to the area. No radiation of pain down the arm. Pt advised to continue CLARITIN/BENADRYL. Advised 1XN to vaccination should be self limited. Will start MEDROL dose pack if no improvement in 3 days.
Received Pfizer COVID vaccine on 12/29/2020 and 1/9/2021.  On 4/2/2021 developed chills, headache, and nasal congestion.   Tested positive for COVID.
pt recv vax 5SEP97 & 7SEP97 pt devel chickenpox on back of legs;
Swollen uvula; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 09Apr2021 at 11:30 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high (HBP) and penicillin allergy. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), duloxetine hydrochloride (CYMBALTA) and lisinopril (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. 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. On 09Apr2021 at 16:00, the patient experienced swollen uvula. No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen uvula was resolved on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
temp but not measured then became lethargic would suck 2 sucks & stop; blue around mouth, limp, could hardly open eyes, anaphylatic resp difficulty; very sleepy, irritable;
This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient might have been vaccinated with improperly stored ROTATEQ orally, lot # M038847, expiration date: 27-APR-2018 (dose was not reported). Temperature excursion ranged from 47 to 77 Fahrenheit degrees for 1 hour. There was no previous temperature excursion. Digital data logger was used. No adverse effect was reported. No product quality complaint was involved. This one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA012508: US-009507513-1703USA009340.
1 min post administration of J & J COVID 19 pt complained of lightheadedness pt was seated then experienced a episode. Vital signes were obtained B: 100/72 73 Pulse 16 R and 98% Oz. Food was provided and pt was observed for 5 mins symptoms resolved and pt was discharged home.
63-year-old male with a past medical history of right lung transplant, hypertension, hyperlipidemia, type 2 diabetes, GERD.   8/30/2021 to 8/31/2021 patient was admitted for COVID-19 and that admission he received 2 doses of remdesivir and 2 doses of dexamethasone and he was discharged home 9/2/2021 he returned to the emergency department with complaint of generalized weakness. Still taking Decadron.  9/5/2021 Received Tocilizumab 9/6/2021 patient had increased work of breathing, a rapid response was called and he was transferred to the ICU and intubated. 9/11 Patient was made comfort care
COVID 19 Treatment; COVID 19 Treatment; dose 5 (booster); dose 5 (booster); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 57 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Early onset Alzheimer's" (unspecified if ongoing), notes: Early onset Alzheimer's. The patient's concomitant medications were not reported.  The following information was reported: OFF LABEL USE (medically significant), IMMUNISATION (medically significant) all with onset 26Sep2022, outcome "unknown" and all described as "dose 5 (booster)"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Nov2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I got COVID-19 12/25/2022. It started uncontrollable coughing. I had a lot of congestion and sneezing. I went to bed and the next morning I tested positive at home. I had my symptoms for two weeks. A month after I contacted the doctor, because I still have the congestion and uncontrollable sneezing and nose bleeds with itching. This continued two months after COVID-19, and they determined it was allergies. It made no change; I was prescribed antibiotics. I just have finished them, because I feel no better. I believe I have the symptoms of long COVID-19. I have also developed foggy brain and the sneezing has not stopped. I am producing a lot of milky transparent mucus from my nose.
Migraine begin around 2pm Dizziness begin around 3:30-ish pm  Took ibuprofen and limiting time standing or walking around
Patient's wife called in saying that her husband has really low blood pressure as a result of the vaccine.  The exact blood pressure value is unknown.
12/28/2021 to emergency room for nosebleeds, gum bleed, melena, GI bleed and fatigue. Severe thrombocytopenia and acute on chronic normocytic anemia. Required transfusion of blood and platelets. Treated for ITP. Stabilized and discharged on 01/04/2022. Multiple comorbid conditions. Failure to thrive. Patient died 01/14/2022.
Pt. had cough before vaccines were administered and developed generalized rash after vaccines were administered.  Mother informed this reaction on 10/13/05.