chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient vaccinated, injection site was SQ posterior aspect of left UA.  With 12h site swelling began with flu like symptoms with GI symptoms, abdom pain, gas, indigestion, with fever 99.1.  Progressed to anorexia, myalgia, arthralgia, malaise/fatigue, light-headedness, headaches.  The swelling was >120mm 3" below shoulder 4" above elbow on Wednesday.  Site was warm to the touch.  Patient was placed on NSAID Q6H and told to apply a warm compress for the first 24 hours and told the cold compress was ordered Q4H for 30min and continue with NSAID.  Patient check daily by provider.
Information has been received from an RN concerning an approx. 11 year old female pt who in approx. 1993 was vaccinated with a 1st dose of Hep-B and immediately, post vax, the pt developed a headache and raised red area at the site of the injection. The pt sought unspecified medical attention. It was reported that the pt never received the 2nd dose of the series. Additional information has been requested.
Vertigo.  Couldn't walk straight.  Nausea Called doctor's office.   I was told it likely wasn't a result of the vaccine since it had been 3 days since shot.   It was suggested to take Meclizine.  I got Meclizine 25mg from a family member and took it.  Felt better after a few hours.
diarrhea; throwing up; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (141003).  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 04Sep2021 (Batch/Lot number: unknown) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "she had outpatient surgery", start date: 23Aug2021 (unspecified if ongoing); "i feel discouraged and/or depressed." (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization. The following information was reported: DIARRHOEA (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "diarrhea"; VOMITING (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "throwing up".  Additional information: Patient reported after start of therapy she had outpatient surgery 23Aug2021 and had to stop taking her medication from 14Aug2021 to 07Sep2021. Patient answered some of the time to the question how often do you run out of medicine. patient reported after start of therapy she ran out of medicine once because she was waiting for insurance approval for dosage change and received free samples from md. patient answered some of the time to the question how often do you miss taking your medicine when you feel sick. patient reported after start of therapy she had diarrhea and was throwing up after her second covid vaccine on 04Sep2021, which has resolved.  Follow-up attempts completed. No further information is expected.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/14/2022  &  2/8/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Tested positive for cocaine by hair follicle test; This spontaneous case was reported by a nurse and describes the occurrence of DRUG ABUSE (Tested positive for cocaine by hair follicle test) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 010A21A) for COVID-19 vaccination.     Concomitant products included CALCIUM PANTOTHENATE, FOLIC ACID, VITAMINS NOS (MULTI-VITAMINS VITAFIT) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced DRUG ABUSE (Tested positive for cocaine by hair follicle test) (seriousness criterion medically significant). The patient was treated with TERBINAFINE at an unspecified dose and frequency. At the time of the report, DRUG ABUSE (Tested positive for cocaine by hair follicle test) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications mention were Allmax, Epitome Hard Core.  Company Comment - This case concerns a  36-year-old, male patient with no relevant medical history, who experienced the unexpected events of Cocaine use. The events occurred several months after the second dose of Spikevax. The rechallenge/dechallenge result is not applicable. The reporter assessed the events as related to the product. The benefit-risk relationship of Spikevax in not affected by this report, however there was no information in the source document supporting that the event resulted in a persistent or permanent incapacity, life threatening, prolong hospitalization, or the need of medical intervention.   This case was linked to MOD-2021-057634 (Patient Link).; Sender's Comments: This case concerns a  36-year-old, male patient with no relevant medical history, who experienced the unexpected events of Cocaine use. The events occurred several months after the second dose of Spikevax. The rechallenge/dechallenge result is not applicable. The reporter assessed the events as related to the product. The benefit-risk relationship of Spikevax in not affected by this report, however there was no information in the source document supporting that the event resulted in a persistent or permanent incapacity, life threatening, prolong hospitalization, or the need of medical intervention.
Fever 101.7 lasting approximately 10 hours unrelieved by Tylenol or Ibuprofen Muscle aches Headache Sore arm
Initial information received on 17-Sep-2018 regarding an unsolicited valid non-serious case received from a Non-healthcare professional. This case involves an 83 years old patient who received vaccine FLUZONE HIGH DOSE in the gluteal instead of deltoid. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 17-Sep-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, lot UJ000AA via unknown route in the gluteal instead of deltoid. It was case of actual medication due to Vaccine administered at inappropriate site. It was not reported that if any adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
vomiting later on 01/05/21.  Lethargy and hypoxia in pm of 01/06/21.  Hypotension am of 01/07/21.  Hospitalized, intubated, cardiac arrest, died 01/07/21.
Extreme fatigue; Weakness; Tinnitus; Chills/hot flashes; Chills/hot flashes; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 70-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the right arm on 07Sep2021 at 12:00 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin and sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO) and valaciclovir (VALACYCLOVIR); both for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the right arm on 17Aug2021 at 11:30 (at the age of 70-year-old) as a single dose for COVID-19 immunisation and received erythromycin (MANUFACTURER UNKNOWN), cefalexin (KEFLEX) and tetracycline (MANUFACTURER UNKNOWN); on unknown date for unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Sep2021, the patient experienced extreme fatigue, weakness, tinnitus, chills/hot flashes and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events experienced extreme fatigue, weakness, tinnitus, chills/hot flashes and headache was recovering at the time of the report.  No follow-up attempts are possible. No further information is expected.
Red itchy rash on skin about an inch past my injection site, not right at the site, closer to the front of my arm/body. (More anterior?) None  It showed up  8 days after my first vaccine. It was about the size of a quarter the first day I discovered it and bigger the second day (today), about 3 inches in diameter.
Information has been received from a medical assistant referring to multiple unspecified patients. The patients' concurrent condition, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose and route were unknown, lot # M004116, expiration date on 12-OCT-2017). No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
fever to 104, chills and rigors, redness and tenderness of L deltoid where shot administered
STABBING PAIN HEAD TO FEET, CHILLS, SWEATING, BLINDING HEADACHE FOR EIGHT HOURS.
she was instructed to continue topical tretinoin cream and also obtain human papillomavirus (HPV) immunization; Literature report: Pediatric Dermatology. 2020.  This literature marketed report has been received from authors of the literature article entitled as stated above. Treatment of verruca plana was often challenging, and multiple treatment modalities, both pharmacologic and destructive, were frequently necessary to clear lesions.  This report referred to a 16-year-old girl presented to the dermatology clinic with a 2-year history of asymptomatic, flesh-colored, flat, polygonal papules of the forehead, temples and upper periorbital skin. She reported fairly rapid onset and gradual growth of papules to current size. She had previously seen another physician and had been misdiagnosed with acne vulgaris. Subsequently, she was prescribed topical 0.1% tretinoin cream, which she had used aggressively prior to dermatology evaluation. On dermatology evaluation, she was diagnosed with verruca plana. After treatment options were discussed, the patient decided to pursue photodynamic therapy (PDT) but wanted to delay her treatment for several months. In the meantime, she was instructed to continue topical tretinoin cream.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (dose, strength, route, lot# and expiration date were unknown) for verruca plana (off label use).  When the patient presented for follow-up six weeks later, she reported an approximate 50% improvement in the number of lesions and requested delay of PDT in favor of continuing current treatment. Six weeks after that, her skin had completely cleared. She had still only obtained her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) immunization but pledged to get the second and third doses.  A copy of the published article is attached as further documentation of the patient's experience.
Patient received Pfizer COVID vaccine on 8/24/22 (lot # FT9142), but as a 2nd dose patient was given Moderna COVID vaccine on 9/14/22 (lot # AS1412B) instead of the correct Pfizer COVID vaccine. Patient ended up receiving Moderna COVID vaccine on 10/17/22 (lot # AR9236B) to finish the series since the 2nd incorrect Moderna dose was given too soon. No adverse event occurred, but this was an administration error.
Information has been received from a registered nurse who reported what read an article. In the article was reported that a female patient died because of the serious adverse event due to GARDASIL. The patient was not the reporting nurse's patient and she did not have a copy of the article. This is a unconfirmed report. Attempts are being made to verify the existence of an identifiable patient. Additional information has been requested.
Unsure at this time. Suspected Kingella Osteomyelitis. Child is walking with a limp and runs a fever periodically.
Got a booster dose from Moderna and got a full dose of 0.5ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Got a booster dose from Moderna and got a full dose of 0.5ml) 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 17-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Jan-2022, the patient experienced ACCIDENTAL OVERDOSE (Got a booster dose from Moderna and got a full dose of 0.5ml). On 17-Jan-2022, ACCIDENTAL OVERDOSE (Got a booster dose from Moderna and got a full dose of 0.5ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
She felt tired after receiving the vaccine and it was for about 3 days; I was just little tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 23Sep2021 (Lot number: 30135BA) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma; "Epilepsy" (unspecified if ongoing), notes: Verbatim: Epilepsy. Concomitant medication(s) included: FLU VACCINE VII; ALBUTEROL [SALBUTAMOL] taken for asthma.  The following information was reported: FATIGUE (non-serious) with onset 26Sep2021, outcome "recovered", described as "She felt tired after receiving the vaccine and it was for about 3 days; I was just little tired".  Additional information: The reporter stated that I have a consumer on the line that received her first dose of the Pfizer Covid-19 Vaccine a couple weeks ago and is scheduled to receive the 2nd dose this Thursday and she had mentioned to me after having the 1st dose that she felt tired after receiving the vaccine and it was for about 3 days.  No follow-up attempts are possible. No further information is expected.
Second dose given 14 days sooner than manufacture recommended interval of 28 days. No harm to patient. Patient made aware of possible need to receive one additional dose 28 days from the date of 2/6/2021 vaccine dose given in order to ensure effective immunity, based on the most current CDC guidance. Verbalized understanding.
Severe Headache 10 hours post injection. Duration: 12 Hours Dizziness 18 hours post injection. Ongoing 54 hours later  Hives on forearms 20 Hours post injection. Ongoing 54 hours later.
Dispatched at 1709 for a 11 year old female near syncope. Pt pale, cold, hypotensive. Placed pt on O2 via NC. Pt transported at 1719 to ER by rescue squad. Run completed without incident. Given crackers and juice at ED. D/C to home.
Chief Complaint: cough, SOB, weakness X 3 days Additional Medical History:  Patient is brought to the emergency department by her daughter with complaint of generalized weakness, fever, cough, and shortness of breath over the last 3 days.  Patient urine has been dark.  Daughter states that multiple family members have been "sick", but have tested negative for Covid.  Patient is vaccinated against Covid.  Daughter states that the patient's cough has gotten progressively worse make it difficult for her to breathe.  Patient denies any complaints in the emergency department.
Recurrence of cutaneous CD30 positive lymphoma following mRNA vaccine; Recurrence of cutaneous CD30 positive lymphoma following mRNA vaccine; This is a literature report for the following literature source(s):  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose unknown number, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cutaneous lymphoma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CUTANEOUS LYMPHOMA (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "Recurrence of cutaneous CD30 positive lymphoma following mRNA vaccine". The patient underwent the following laboratory tests and procedures: CD30 expression: Positive. Sender's Comments: Based on the limited information provided in this case, a contributory role of the suspect product BNT162b2 (COMIRNATY) to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information.
Delayed swelling and redness. May have been present longer but I didn't notice it until April 8th; it seems to be larger today (April 11), redder, more swollen. A little warm and slightly itchy but not painful.
Developed inflammation in fingers. Was diagnosed with RA. (Rheumatoid Arthritis)
This case was reported by a physician and described the occurrence of urticaria in a 46-year-old male subject who was vaccinated with Havrix, for prophylaxis. Medical history included anxiety and heartburn. Concurrent medications included Zoloft and Nexium.  On 24 August 2006 at 5:00 p.m., the subject received 1st dose of Havrix (1 ml, intramuscular, left arm). On an unspecified date in September 2006, on or prior to 12 September 2006, less than one month after vaccination with Havrix, the subject experienced urticaria. The subject was treated with Benadryl, "which temporarily improved the symptoms, but caused drowsiness". At the time of reporting, "the symptoms persisted and the prescriber was considering alternate treatment medications". As a result of this event, the immunization series with Havrix was discontinued. The physician considered the urticaria was probably related to vaccination with Havrix. Follow-up was received by the subject on 06 November 2006. On 18 September 2006, the subject was treated with fexofenadine. The outcome of the events following treatment with fexofenadine was not reported.
5yr old patient Imm. given in office 5/14/14. Fever 100-101 began 5/15/14 AM. (+) area redness (6x4cm) to rt deltoid area; 1 cm area circular erythema to rt. Posterior fat pad. (Satellite red papules/welts proximal to this). Tx fever/pain with ibuprofen.
woke up and was not good; Neck, arm and body hurt completely; Headache; Neck, arm and body hurt completely; bit of sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (bit of sore arm), FEELING ABNORMAL (woke up and was not good), NECK PAIN (Neck, arm and body hurt completely), HEADACHE (Headache) and MYALGIA (Neck, arm and body hurt completely) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032321A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol since 2006. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PAIN IN EXTREMITY (bit of sore arm). On 13-Apr-2021, the patient experienced FEELING ABNORMAL (woke up and was not good), NECK PAIN (Neck, arm and body hurt completely), HEADACHE (Headache) and MYALGIA (Neck, arm and body hurt completely). The patient was treated with CORTISONE at a dose of 1 shot. At the time of the report, PAIN IN EXTREMITY (bit of sore arm), FEELING ABNORMAL (woke up and was not good), NECK PAIN (Neck, arm and body hurt completely), HEADACHE (Headache) and MYALGIA (Neck, arm and body hurt completely) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Body temperature: 101.5 (High) 101.5°F.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-271732 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Significant FU -Batch number, medical history, concomitant and treatment medications added.
Muscle aches, low grade fever starting on 11/29 increasing to 101 by that night. Also redness on left arm from shoulder to almost the elbow, tender to the touch and warm. Also very tired 11/19 and 11/30 and slept a good portion of the day.  No fever on Saturday and started feeling better by Sunday.  The rash did last until Monday but decreased a little at a time.  Took Tylenol.
Report 2001029378-1 describes fever in a 27 year old female who received an injection of hep B vaccine recombinant (Engerix B). This report was received from the vaccinee's sister, who is a nurse. Medical history, concurrent conditions, and concurrent medications were not specified. The pt had no adverse experience following receipt of her first injection of Engerix B. On 12/6/01, the pt received her second injection of Engerix B. An unspecified time post-immunization, she experienced fever, chills, sweats, and flu-like symptoms.
My son received the vaccine Meningococcal B on Friday, September 14, 2018 at 3:30 pm. We went home after the injection and my son complained that his arm was very sore. I told him to ice it, and he tried but it was very painful to keep the ice on it. He went to his dads for dinner and came home saying he was very dizzy and had a bad headache. He felt very hot so I took his temperature. It was 101.5.  He said he was going to lay down as he felt like he was going to pass out. He slept all night and most of the next day. He woke up hungry but had a fever of 102.1. He tried eating some spaghetti, but he was very nauseous. He had a bad headache, all his joints ached, and muscles ached and very tired. He had the chills and fever still 102. The injection site was very hot and red and swollen. I took him to the ER to have him checked. The doctor thought he had an abscess at the injection site as it was so swollen and red. He did an ultrasound on his arm, and it looked ok.
I am reporting on a breakthrough COVID-19 case. On Thursday, 5/4/2022, I went to get tested for COVID-19 for F departure and tested positive first and isolated from my group. Three hours later I tested negative with a self-test and was allowed to travel. Trying to get home from traveling. Went to testing site and also tested negative. I was able to fly home. The flight was about 36 hours long and went to 5 different airports. Upon returning home, I tested positive with a home test on Saturday evening 5/7/2022. This means I was infectious during the entire flight and probably infected everyone around me. I was prescribed a drug called Paxlovid as an emergency use drug. Also, I started feeling bad on the overnight flight. I had a center seat and could not get comfortable. I am continuing to get better.
Reports onset of "rash" with redness/itching to right side of face, back of hands and inner thighs/buttocks on evening of 10/27/2017.