chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I just got over my bout wit shingles,even after having the shot/Suspected vaccination failure; I just got over my bout wit shingles; I hear the Covid virus is a good precursor; This case was reported by a consumer via interactive digital media and described the occurrence of 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and covid-19. On an unknown date, the outcome of the vaccination failure and covid-19 were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient stated that he/she just got over his/her bout with shingles even after having the shot. The patient also stated that he/she heard the Covid virus was a good precursor, hopefully never again. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available. The event covid-19 was conservatively captured.
Received vaccines on December 5, 2008 seen at ER on 12/7/08 due to erythema and swelling of left thigh measuring 14x12 cm. Dx cellulitis started on Augmentin. Seen for followup 12/8/08 with erythema decreasing and no mobility limitations.
Patient was given the pfizer 5-11 vaccine when she is 12 years old.
After booster!  Fever 101.8 Aches, Nausea, headache Lasted 2 days
Patient had a 3 day delayed possible reaction to the Fluad. Patient experienced "fever, chills, diarrhea, fatigue, and muscle/joint pain.  He described his stomach pain as feeling like he was punched in the stomach.
pharmacist calling to report a Menveo vaccine was given to a child less then 10 years of age; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a child patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: pharmacist calling to report a Menveo vaccine was given to a child less then 10 years of age). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date 16 August 2023: The pharmacist calling to report a Menveo vaccine was given to a child less then 10 years of age. No other information was known at this time.  The reporter consented to follow up.  The patient less than 10 year old received menveo which led to inappropriate age at vaccine administration.
Vaccine expirition date was revised 8/31/2022 after the vaccine was revised.
This spontaneous report as received from an office manager refers to multiple patients of unknown age and gender. There was no information about the patients' concomitant medications, allergies and pertinent medical history reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot# M037771, expiry date: 21-FEB-2019, lot# M039642, expiry date: 03-JUL-2019, lot# M035487, expiry date: 23-FEB-2019, lot# M022077, expiry date: 10-MAR-2019, (dose, route and site of administration were not reported). No adverse effects were reported. The temperature was total time in the range of 9°C to 25°C for 3 hours. There was no previous temperature excursion. The call was because of data logger.  Additional information has been requested.; Sender's Comments:  US-009507513-1703USA013727:
Tested postive for Covid-19 following second vaccine shot; Tested postive for Covid-19 following second vaccine shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Nov2021, outcome "unknown" and all described as "Tested postive for Covid-19 following second vaccine shot". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Nov2021) postive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
I had gone to the restroom and realized that I had a fair amount of bright red blood when I wiped and realized I was bleeding vaginally. It became a darker blood the next day and was much a smaller amount and I have not had anything since then. I had my annual women's exam and I discussed this with them, and they did do an Ultrasound but wanted me to do another with an ultrasound tech as he did not find anything. On the second ultrasound they did see that walls of my uterus were thickened, and they were unable to see into the cervix. so they are having me come in for a Heterotopic DNC to take another look as well.
A 20-year-old patient received a pediatric dose of VAQTA; A 20-year-old patient received a pediatric dose of VAQTA; This spontaneous report has been received from a pharmacist, regarding to a 20-year-old patient of unknown gender. On an unknown date, the patient was vaccinated with a pediatric dose (product administered to patient of inappropriate age and incorrect dose administered) of hepatitis a vaccine, inactivated (VAQTA) 0.5 milliliter (mL) (scheme vaccine, route of administration, anatomical location, lot number and expiration date were not reported), as prophylaxis.
Patient presented to the ED and was subsequently hospitalized for chronic dyspnea and hospice care within 6 weeks of receiving covid vaccination. She died on 3/6/2022
Post vax, the employee reported to employee health on 8/21/01 with a fine, papular rash all over his body. No vesicles or hives; no respiratory involvement but complained of fever, itching and discomfort with the rash.
This spontaneous report as received from a healthcare worker refers to a pediatric patient of unknown age and gender. On an unknown date in 2014 the patient was vaccinated with a dose of VARIVAX (0.5 ml, subcutaneously, LOT#, dose and expiration date not reported), which was exposed to -12C for 15 minutes between the dates of 22-APR-2014 and 08-MAY-2014. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient's son called to report that after receiving vaccine on Friday 6/17/22, today Sunday 6/19/22 this morning around 10:30am patient experienced dizziness and fainted while making hot tea, causing the teapot of hot tea to fall and spill onto him and burn him severely.
Painful macules started on hands, later on feet and progressed to mid arms. Fainted. Rash on abd & back with soft palate involvement. (Erythema multiforme) minor.
Pain, redness, red bands down arm, fever X1 day and swollen lymphnodes X1 day.
soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the husband of a friend received shingrix and had soreness at the site of injection.
Severe and multiple welts accompanied with stinging. Welts covered bicep and underarm area. Symptoms resolved with use of BENADRYL.
stomach pain; This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain) in an 18-year-old male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Wheezing, angioedema, tachypnea.  In office: required albuterol, Epi-pen Jr, Benadryl.
My menstrual cycle began 13 days late and I believe it may be connected to the vaccine booster, as I have been very regular for the past several years. My last period began on 10/27 and, although feeling symptoms around a month later such as cramping, I did not start my next cycle until 12/10.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21 and 042120A) for COVID-19 vaccination.     Concomitant products included MELOXICAM and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            On 4 Mar 2021, the patient experienced the event sore arm after 2nd dose. She did not take her arthritis medication on either days when the vaccine was administered she said since it is an anti-inflammatory. Wants to know if she can restart the medication now.  Treatment details included has not taken anything yet but plans on trying acetaminophen after call completes.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event sore arm was unknown.
PATIENT WAS NERVOUS ABOUT RECEIVING VACCINE. AFTER VACCINE WAS ADMINISTERED, HE APPEARED PALE AND SHAKEY.  HE REMAINED SEATED.  HE SAID HE THOUGHT HE WAS "GOING TO THROW UP".  PATIENT VOMITED.  HE DENIED ANY OTHER SYMPTOMS (SUCH AS ITCHY THROAT OR MOUTH OR ANY DIFFICULTY BREATHING). AFTER 10 MINUTES, HE FELT BETTER.  HE WAITED ANOTHER 15 MINUTES IN THE LOBBY, AND GAVE A THUMBS UP ON HIS WAY OUT.  2 HOURS LATER, I SPOKE WITH HIS MOTHER TO CHECK IN. HE WAS DOING JUST FINE.  NO OTHER ISSUES TO REPORT.
This spontaneous report was received from a registered nurse reporting on a 20-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 16-MAR-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection (dose, frequency and route of administration were not reported, lot # either L050561 with expiration date of 14-DEC-2017 or M019841 with expiration date of 20-APR-2018), for prophylaxis. The Merck (MRK) sterile diluent (lot # and expiration date were not reported) used to reconstitute the VARIVAX was properly stored. The temperature excursion ranged from 6 to 14 degrees Fahrenheit and lasted for 30 minutes. It occurred once on 03-FEB-2017, and was detected by a Digital Data Logger. There was no previous excursion reported. No adverse effects were reported. This was one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA010916: US-009507513-1704USA009837:
muscle pain from her shot; fatigue; headaches; This is a spontaneous report from a non-contactable consumer. An adult (18-64 years) female patient (reporter's sister) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), intramuscularly on 20Jan2021 at single dose for COVID-19 immunization, administered in a hospital. The patient is not pregnant. The patient's medical history was not reported.  There were no concomitant medications. The patient had no other vaccines in four weeks. The patient got the fatigue, headaches and muscle pain from her shot on 20Jan2021. It was unknown if treatment was received for the events. It was unknown if the patient had COVID prior vaccination and if the patient has been tested for COVID post vaccination. The outcome of the events was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Dec2021 as dose 3 (booster), single (Lot number: Fj1611) at the age of 26 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Feb2023, outcome "not recovered", described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset Feb2023, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (Feb2023) negative, notes: 7 days later tested negative for covid; (Feb2023) positive, notes: Then tested positive for covid again one day later. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 12Feb2023 to 16Feb2023.  No follow-up attempts are possible. No further information is expected.
9SEP92 cold sx; 12SEP92 t100 ax; 13SEP92 t106 R;
Previous Td was March 2003. From HPI dated 12 Apr 07: Experienced onset of typical soreness at vaccination site followed by eruption of red raised areas. Has noticed associated dyesthesias with wearing his watch and clothing over his left arm to his wrist. Vague pain near posterior shoulder and neck. Reports previous hx of frozen shoulder after tetanus vaccine as a child. Left deltoid region with several raised erythematous and edematous plaques some with central papulovesicular change. No purpura, necrosis or crusts. Left hand no suspicious acral lesions. Apr 17: over past 5 days reports few new lesions on forearms and darker red color to older sites around shoulder. Also described episodes of 5/10 pain at shoulder site at rest and with arm elevation. Baseline 2/10 pain. No new lesions past day or so. Has several plaques of coalescing red to red brown papules over deltoid region with few scattered down to forearm. Some with focal superficial crusts. Diagnosis: 1. Brachial Neuritis 2.0 Arthus Reaction. Lesions, plaque 4/09/2007, lesion Vesicle 04/09/2007. Pain 04/09/2007 left shoulder and neck. Edema at injection site 30-50mm 04/07/2007. Paresthesia 04/09/2007 dysesthesia.
Area where DTaP given was very red, swollen, and hot to touch. Cause patient discomfort.
After around 15 minutes, blotchy red patches appeared on both my left and right forearms. Random itchy spots occurred in different areas of my body such as scalp, chest, legs and nose. My arms were not itchy. I took Benadryl when I got home and the redness and itchiness went away.
Received the J+J Janssen vaccine on Sunday 3/14/21. On Friday 3/19/21 developed bilateral lower leg discomfort and red spots on outer part of shin. On Sunday 3/21/21 noted increase in swelling both feet and lower legs with pain and rash waist down.  Patient went to ER for evaluation.  Started on prednisone.  Dx:  Vasculitis On Monday 3/22/21 evaluated by PCP.  Follow up blood work and office appointment in 8 to 10 days. Report to VEARS.  Awaiting patient call back to complete form. On Wednesday 3/24/21 patient returned call.  Reports joint aches, right side decreased swelling, left foot and hand remains slightly swollen.  Purple skin discoloration remains on lower extremities but decreased pain.  VEARS form submitted.
Narrative: 78yo male with history of ALS - Amyotrophic lateral sclerosis, dysphagia, essential hypertension, acquired dysarthria, malnutrition, HLD, sleep apnea, and placement of gastrotomy tube. Died on 06/17/2021. Patient was administered covid vaccinations on 01/29/2021 and 02/19/2021 at an outside facility. Appears patient died due to complications of ALS and death is not related to the covid vaccinations.
Information has been received from a nurse concerning her 16 year old granddaughter with a dust allergy and a history of sinus infection who "sometime in 2007" received an unknown number of vaccinations of Gardasil (lot numbers not provided) when she was 15 years old.  It was reported that in the beginning in the fall of 2007 the patient experienced crying a lot and gone to a psychologist for treatment.  The patient also hurt her knee at sometime and is unable to play soccer.  The patient's crying a lot and hurt knee persisted.  No further information is available.
HEADACHE, CHILLS, SWEATS, MUSCLE ACHES Narrative:  OTC TYLENOL
Around 30 minutes after injection,  I developed numbness around the mouth area to include a metallic taste. Around 600 p.m. is when I started feeling tightness in my chest and urges to cough. 645 is when I developed facial swelling and hives . My husband administered 50 mg Benedryl . I woke the next morning  11/4/20 still having  pockets of swelling in my face and chest tightness.
tightness and heaviness in her upper chest; breastfeeding following vaccination; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (tightness and heaviness in her upper chest) and MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding following vaccination) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020b21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No significant historical event reported.). Concomitant products included LEVOTHYROXINE, ASCORBIC ACID (VITAMIN C ACID), PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE], VITAMIN D3 and PROBIOTICS NOS for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding following vaccination). On 06-Apr-2021, the patient experienced CHEST DISCOMFORT (tightness and heaviness in her upper chest). On 02-Apr-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding following vaccination) had resolved. At the time of the report, CHEST DISCOMFORT (tightness and heaviness in her upper chest) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment taken with Advil, the day after the shot.
Information has been received from a pediatric resident physician concerning an approximately 6 month old patient who on an unspecified date was vaccinated with a dose of ROTATEQ (lot # not reported) orally. On an unspecified date the patient was diagnosed with intussusception and on an unspecified date the patient was hospitalized. Intussusception outcome was unknown. Additional information has been requested.  11/10/2009 hospital records for 8/11-8/14/2009.DC DX Intussusception.  patient with c/o's fever, nausea, vomiting, abdominal pain, blood in stools, and lethargy. Abd Us + for intussusception which was reduced. Tx: IVF, IV ABX.
Pt. states that she developed bilateral facial redness around mouth around 09:50 am after receiving the first  pfizer vaccine to left arm at 09:40 am.
When I received the vaccine I did not feel anything, 12hrs after the vaccine my arm suddenly became very sore. I developed severe chills and low grade fever, muscle and joint pain, my hands and feet were cold, headache, and uncontrolled yawning, I suppose my body's attempt to cool the brain. I took 600 mg of ibuprofen and the symptoms mostly abated, but returned about 4hrs later. I am treating myself with ibuprofen and acetaminophen. I have not seen my PCP, I feel the symptoms will resolve with time, if not I will follow-up. I cannot find anything in the literature but do people that have had covid get a stronger reaction from the vaccine?
Within 7 hours of receiving the Flu Mist, I had a severe headache and fatigue. The next morning when I woke up  my nose, sinuses and throat where sore and completely dried out.  For the next seven days I kept a constant headache, body/muscle aches, dry mouth/throat,nasal passages and a low fever off and on but mostly I was extremely faigued.  I went to see the doctor on Tues. Nov 2nd.  He said he believed I had a bad reaction to the flu mist. My mucous membranes where dried out and my sinuses red and swollen. I had most of these symptoms until 12/4.
patient developed a skin collored papular nonpruritic rash on arms and face 5 days after receiving hpv and tdap vaccines. came to the doctors to be evalauted for the rash. no other symptoms or sequelae
Pt tested positve for COVID on 10/26/2021. Pt is a known cae of atrial fibrillation, high blood pressure and chronic kidney disease who presented to the hospital on 10/26/2021 with acute respiratory failure related to COVID pneumonia.  Treatment with IV steroids and IV remdesivir.  oxygen.  Afib controlled on cardizem and rythmol.  Discharged to home.
This spontaneous report was received from a nurse refers to a 12 month old patient of unknown gender. Concurrent condition and medical history were not reported. On 07-JUL-2015, the patient was inadvertently administered a dose of (Merck) VARIVAX, 0.5 ml subcutaneous (strength, dose #, anatomical location and lot # were not provided) and a dose of (Merck) PROQUAD 0.5 ml subcutaneous (strength, dose #, anatomical location and lot # were not provided) (overdose). There was not concomitant medication reported. No adverse events were reported. At the time of the report, the outcome of overdose was unknown. The relatedness of the adverse event and the vaccines (Merck) VARIVAX and (Merck) PROQUAD was not provided. Additional information has been requested.
Had large local reaction start on 3/4 which resolved by 3/5. Seemed fine and then 3/8 work up very fussy refusing to walk and with mild petechial rash. Diagnosed with likely serum sickness like reaction.