chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 03/20/21pfizer,Lot#ER8727 2nd dose:04/10/21 ,Pfizer,Lot# EW0150 Diagnosed covid positive:07/26/21 Symptom onset: Exposure:Travel Symptoms:Asymptomatic
Patient came in to office to receive 3rd dose (bivalent) of Pfizer COVID-19 for ages 5-11. In error, the Pfizer 6month-4year COVID-19 bivalent was drawn up and administered to patient. According to CDC guidelines (Appendix D Vaccine administration errors and deviations), since the patient received the wrong product resulting in a lower-than-authorized dose, the patient was called back to the office to repeat the dose immediately.
This spontaneous report was received from a pharmacist refers to a 73 year old female patient. On 14-FEB-2013, the patient was vaccinated with ZOSTAVAX lot # H020001, expiration date: 02-FEB-2014, 0.65 ml, subcutaneous. Concomitant therapies included NORVASC. The pharmacist reported that on 15-FEB-2013, the patient experienced injection site reaction of redness and swelling the size of a quarter. The event was unknown. The relatedness between the event and ZOSTAVAX was unknown. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 31-OCT-2014, the patient was inoculated at a health department with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 05-JUN-2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
DEATH; This spontaneous report received from a consumer via a social media via a company representative concerned 2 patients of unspecified age and sex. The patients' weight and height were not reported.  No past medical histories or concurrent conditions were reported. The patients previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1, unspecified manufacturer) (suspension for injection, route of admin, and batch numbers were not reported) dose was not reported, 1 total, administrated on an unspecified date for prophylactic vaccination. It was unknown if patients had adverse reactions post vaccination (Dose number in series 1). The patients received covid-19 vaccine ad26.cov2.s (Dose number in series 2, unspecified manufacturer) (suspension for injection, route of admin, and batch numbers were not reported) dose was not reported, 1 total, administrated on an unspecified date for prophylactic vaccination. The batch numbers were not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patients died after second dose (Dose number in series 2). It was reported as "We know of three people personally also who died within days of their 2nd Vax". The cause of death was unknown. It was unspecified if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220100153.; Sender's Comments: V0: 20220100127-covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
covid vaccination on 2/8/21.  2/9/21 arm with welt a little sore, was exhausted by end of day.  On 2/10/21, felt intense fatigue.  Took temp and was 102 temp.  On 2/11/21 had sores in mouth--now gone.  Welt on arm is now gone.  Has been fine ever since.  Never had cold sores in past.
Within 24 hours a 3 yo developed a hive like rash on trunk of body. Initially a rash up right leg from injection site - slight fever w/i 10 hours.
2 days after receiving his first vaccine, he developed muscle and bone pain.  Symptoms continued and he did get his second vaccination.  These were done in in his home state.  I am in a different state.  I saw him last week and he had muscle pain and arthritic symptoms.  Sedimentation rate was elevated.  Started on prednisone with some improvement.
Information has been received regarding a case in litigation concerning an approximately 18 month old male who was injected IM with vaccinations containing the mercury based preservative thimerosal. The alleged result of the vaccinations is the pt suffered mercury toxicity and permanent neurological injuries, and associated complications with aggravation of other conditions directly through exposure of mercury. In approximately August 1999, at approximately 18 months of age, the pt suddenly regressed developmentally, losing milestones of neurological development previously achieved specifically including but not limited to becoming withdrawn, unable to speak, unresponsive to his environment, engaging in repetitive behavior and loss of language skills, motor skills and affect. Immunization information indicated the pt was injected with the following vaccines that contained thimerosal: hep B vaccine recombinant (625097/1313E) on 3/20/98. Concomitant therapy included Tripedia on 4/21/98 (0916480), 6/3/98 (0932710), 9/10/98 (0942540); ActHIB on 4/21/98 (0915230) and 9/10/98 (0954530); hep B on 2/18/98 (2361B9) and 9/10/98 (2703A9); and Haemophilus B conjugate vaccine on 6/30/98 (627433/0722H). Upon internal review, the pt's mercury poisining and neurological disorder were considered to be an other important medical event (OMIC). No further info is available.
Information has been received from a physician concerning a female (approximately 24 year old) with history of an abnormal Atypical squamous cells of undetermined significance (ASCUS) PAP smear in 2006 and 2007 who was vaccinated with her first (lot#656048/0187U), second (657621/0387U) and third (658558/1061U) dose of GARDASIL on 06-MAR-2007, 07-MAY-2007 and 05-SEP-2007 respectively. Concomitant medications included unspecified birth control. They did not test for HPV at the PAP smear in 2007. She had another PAP smear in November 2007 which showed high grade dysplasia. The patient had a colposcopy which showed that she had high grade squamous epithelial lesions. She also had a cold cone biopsy on 21-DEC-2007 which came back positive for squamous metaplasia. The first PAP smear she received in 2008 was normal but the second came back as positive for HPV. She had another PAP smear in January 2009 that came back as normal. The outcome is unknown. The patient's sister also experienced an adverse event following vaccination (WAES# 0902USA01061). The patient sought medical attention. Additional information has been requested.
feel sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): 3210-2208807018 (RA).  A 52-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history included: "allergy to onions" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "depression" (unspecified if ongoing); "pre-diabetes" (unspecified if ongoing); "Multiple sclerosis" (unspecified if ongoing); "COVID multifocal pneumonia" (unspecified if ongoing); "weight loss" (unspecified if ongoing); "Seizure" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; XIGDUO; MOUNJARO; DULOXETINE; PROPANOLOL [PROPRANOLOL]; METHYLPHENIDATE; EVUSHELD; AMOXICILLIN; ZITHROMAX Z-PACK; MODERNA COVID-19 VACCINE taken for covid-19 immunisation as dose number unknown, single. Past drug history included: Codeine, reaction(s): "allergy to codeine"; Morphine, reaction(s): "allergy to morphine". Vaccination history included: Covid-19 vaccine (Primary Immunization Series Complete; Unknown Manufacturer), for COVID-19 immunization. The following information was reported: MALAISE (non-serious) with onset 31Dec2022, outcome "unknown", described as "feel sick".  Additional information: Patient stated that she had the Bivalent shot on 28Dec2022 and started to feel sick (not further clarified) on 31Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash all over body approx 2 wks p/infection; Had temp 104 was dx ear infect & given ATB; Rash lasted approx 5 or 6 days;
Day 33 and has not received the second dose; Intestinal Pain; Urinary Tract Infection (UTI); Little sore left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INCOMPLETE COURSE OF VACCINATION (Day 33 and has not received the second dose), URINARY TRACT INFECTION (Urinary Tract Infection (UTI)), GASTROINTESTINAL PAIN (Intestinal Pain) and VACCINATION SITE PAIN (Little sore left arm) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (Little sore left arm). On 09-Mar-2021, the patient experienced URINARY TRACT INFECTION (Urinary Tract Infection (UTI)). On 14-Mar-2021, the patient experienced GASTROINTESTINAL PAIN (Intestinal Pain). On 15-Mar-2021, the patient experienced INCOMPLETE COURSE OF VACCINATION (Day 33 and has not received the second dose). On 13-Feb-2021, VACCINATION SITE PAIN (Little sore left arm) had resolved. At the time of the report, INCOMPLETE COURSE OF VACCINATION (Day 33 and has not received the second dose), URINARY TRACT INFECTION (Urinary Tract Infection (UTI)) and GASTROINTESTINAL PAIN (Intestinal Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication included nitrofurantoin for urinary tract infection and stopped the antibiotics later due to intestinal pain. Company Comment:This report refers to a case of incomplete course of vaccination for mRNA-1273, lot # 007M20A  with associated AEs vaccination site pain, urinarty tract infection and gastrointestinal pain NOS.; Sender's Comments: This report refers to a case of incomplete course of vaccination for mRNA-1273, lot # 007M20A  with associated AEs vaccination site pain, urinarty tract infection and gastrointestinal pain NOS.
pt recv vax 2JUN95 & 18MAY97 pt devel varicella all over body x/head;tx w/amoxil & APAP;
On 5/6/02, pt reports that left deltoid to elbow is swollen, firm, painful and warm to touch X 3 days. Improving slight each day. Treated with Zyrtec 10mg po q 2 X 4 days.
Patient had fever, chills, and fatigue. Subsequently, he developed one month of panic attacks.
Pt had a pre-op test for COVID that was positive prior to right hip arthroplasty and is asymptomatic
This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition, historical medication and concomitant medication. On an unknown date the patients were vaccinated with improperly stored VAQTA, lot # M017982/expiration date- 13-SEP-2017, lot # L027735/expiration date- 12-JAN-2017, lot # M009786/expiration date- 26-MAY-2017, lot # L036449/expiration date- 26-MAY-2017 and lot # M027879/expiration date- 24-JAN-2018, lot # M032492/expiration date- 02-MAR-2018. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Case PHEH2016US024281 is an initial spontaneous report received from consumer on 19 Sep 2016. This case refers to 5 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported, expiry date: not reported) on an unknown date. It was reported that the patient received FLUVIRIN last year from her allergist in split doses 30 minutes apart and she was fine. No adverse event was reported following this medication error.
Sudden and severe hearing loss in left ear.; full ear feeling; vertigo; dizziness; motion sickness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Dec2022 at 15:30 as dose 4 (booster), single (Lot number: GJ6738), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arnold Chiari Malformation" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing); "Known allergies: Avocado" (unspecified if ongoing). Concomitant medication(s) included: PROPRANOLOL. The patient had no other vaccine in four weeks. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), unknown manufacturer), for COVID-19 immunization. The patient had no covid prior vaccination. The following information was reported: DEAFNESS (disability, medically significant) with onset 21Dec2022 at 03:30, outcome "not recovered", described as "Sudden and severe hearing loss in left ear."; DIZZINESS (disability) with onset 21Dec2022 at 03:30, outcome "not recovered"; EAR DISORDER (disability) with onset 21Dec2022 at 03:30, outcome "not recovered", described as "full ear feeling"; MOTION SICKNESS (disability) with onset 21Dec2022 at 03:30, outcome "not recovered"; VERTIGO (disability) with onset 21Dec2022 at 03:30, outcome "not recovered". The events "sudden and severe hearing loss in left ear.", "full ear feeling", "vertigo", "dizziness" and "motion sickness" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Dec2022) Negative. Therapeutic measures were taken as a result of deafness, ear disorder, vertigo, dizziness, motion sickness including steroid injection x3 into the ear and oral medicine.
This spontaneous report as received from a Registered Nurse regarding a 9 year old Child patient of unknown gender. There was no information about concurrent condition, historical medication and concomitant medication. On 03-DEC-2018, the patient was vaccinated with improperly stored PROQUAD for prophylaxis (product storage error). Vaccine was stored out of range at -6 degrees for an approximate time of 15 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA001085.
C/O front headaches continuing since given nasal H1N1 vaccine on 11-6-09. Still seeking treatment.
Moderna Covid-19 Vaccine EUA Large spreading rash starting 1/31 and has not yet cleared. Headache starting 1/21 lasting 2 days Sore arm lasting several days General body aches for 3 days
blister near the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site blisters in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On 25th November 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular) .5 ml. On 25th November 2019, less than a day after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site blisters. On an unknown date, the outcome of the injection site blisters was not recovered/not resolved.   It was unknown if the reporter considered the injection site blisters to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The batch number was not reported. The patient received the vaccine at the hospital and that same day in the evening the patient noticed a blister near the injection site, left upper arm. Vaccine was administered intramuscularly in the left upper arm, 0.5 ml. The patient states the blister was starting to improve at the time of reporting. No additional information was provided.
I GOT THE SHOT ON APR 8 2021 AND ON APRIL 12 2021 I STARTED HAVING DIARRHEA AND HAVCE HAD IT EVERY DAY SINCE. TODAY IS APRIL 22. 2022. NOT ALL DAY, MAYBE JSUT IN THE MORNINGS.
States that she was sore the next day and then diagnosed with acute bronchitis 3 days later. Started bruising about a week after shot.  Reported it to us on the 29 and has severe bruising and is still sick
2 days after shot, my arm was sore. I started feeling a ?pinch-type? feeling in my upper left chest. My blood pressure, which is controlled by medicine, has been rising since. I also have had a pressure in the back left portion of my head.
This spontaneous report was received from a pharmacist refers to an about 5-10 patients of unknown age and gender. Medical history was not reported. The pharmacist informed that in August 2014 the patients were vaccinated with ZOSTAVAX vial, subcutaneous (lot number, expiration date and dosage were not reported) which was improperly exposed to defrost cycling up to 7 F for <1 hour per cycle per day each day. The date that this ZOSTAVAX was placed into this freezer was unspecified. No known adverse effects were reported. Follow up information has been received from a pharmacist refers to a 69 years old female patient with knee problems. On 28-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously, (lot#K000994, expiration date: 06-MAR-2015) in the left arm. Concomitant therapy included influenza virus vaccine (unspecified). This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a 9 year old black male with a history of renal transplant in January 2004 secondary to end stage renal disease (ESRD) who on 16-AUG-2004 was inadvertently vaccinated in the left deltoid with a dose of varicella virus vaccine live. Concurrent medications included mycophenolate mofetil (CELLCEPT), tacrolimus (PROGRAFY), and prednisone. On 02-SEP-2004 (previously reported as "approximately one week later") the pt presented with a vesicular rash on his eyelids and ear canals, he was afebrile, and tested positive for VZV, varicella zoster virus. Unspecified medical attention was sought. The physician later reported that the pt was febrile and described the rash as a "diffuse vesicular, pruritic rash - looked like classic chickenpox" and also commented that there was greater than 100 lesions over the trunk, arms, face, etc. As reported by the pt's father the lesions were crusting and healing, then approximately two weeks ago (in October 2004) the child developed another rash thought to be molluscum. The child became super infected with staphylococcus and required antibiotic treatment. As of 11-Nov-2004, the pt had recovered. Tests were performed to type and verify the strain, wild type or varicella virus vaccine live and a specimen was collected from a vesicle type lesion and sent to the laboratory on 07-Sep-2004. As of 10-Dec-2004, the VZV strain was identified as vaccine type. It was noted that the pt had been hospitalized for 14 days (dates not reported). No product quality complaint was involved. Additional information is not expected.
Tdap had been accidentally adminstered rather than Tb for TB skin test.  Patient developed a local reaction to site of administration, a 6cm diameter area of erythematous tender swelling with very firm ~1cm diameter area of central induration on mid-third of right volar forearm.  She also reported increased fatigue and malaise. Symptoms developed within 12 hours of administration and began to resolve within 48 hours. Erythema, fatigue, malaise resolved, but induration still present one week post-administration.
Dizzy, sweaty, chest pain, shortness of breath, nausea, feverish.  Did not seek medical attention at the time.  Came to Health Services on 11-05-2009 at 3:00pm, describing episode of the previous evening, but symptoms had resolved by the time she was seen.
patient developed a rash 4 days after receiving the vaccine, she was given a course of prednisone today
Dysphagia and ear pressure occurred during every meal due to swelling on the right side in the parotid area around April 15th, 2021. In September 2021 it was determined to be salivary gland duct stenosis (see Item 19). Treatment was warm compresses, massages, and increased fluid intake. As of September 29, the stenosis was still present, but symptoms of dysphagia were decreased. As of Nov 16, 2021, the dysphagia is still mildly present but not disruptive. Lymph nodes in the right submandibular region still seem enlarged.  Intense acid reflux, gas pains, and diarrhea starting around April 15th, 2021. Worked with a gastroenterologist, took antacids, and reduced spicy food intake. Was able to re-introduce spicy and inflammatory foods (tomatoes/spicy/sour dishes) with less issue mid September 2021. As of Nov 16, 2021, still more susceptible to intense gas pains and diarrhea, but closer to pre-vaccine state. Ingestion of chocolate causes histamine-related response during following meal (high heart rate, low blood pressure, dizzy). Negative allergy test to chocolate.  Twitching between eyes occurred starting around April 15th, 2021. It resolved within a few weeks without intervention (unsure on timing).  Mild weakness in right side of body was present April 24, 2021-April 26th, 2021; holding up a dish with right hand was challenging, right side of body felt colder, "static" feeling inside right leg. Worked with neurologist but weakness resolved after April 26th, 2021.  Severely heightened anxiety reminiscent of a PMDD flare-up lasted for 3 menstrual cycles (starting from first dose on March 20, 2021). Resting heart rate data was consistent with previous PMDD occurrence (July 2019-Aug 2020; PMDD during 2019-2020 timeframe was caused by the Mirena IUD). Not sure on dates, but fairly certain PMDD resolved by June 21st, 2021 (start of menstrual period).  Mild menstrual cramps day of vaccine. Period was due to arrive on April 16th, 2021, and previous menstrual cycle lasted from March 10th, 2021 to March 16th, 2021. Menstrual cramps resolved without intervention.
Around 12 hours after receiving the booster dose I began to experience fever, chills, body aches, headache and upset stomach. I began taking Tylenol at 14 hours post injection and have been taking regularly since to reduce side effects.