chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Licensed Practical Nurse (L.P.N.) concerning a 17 year old female patient who on 29-NOV-2006 was vaccinated IM with a first dose of Gardasil lot # 653736/0868F and on 10-MAR-2007 with a second dose of GARDASIL lot #654702/0011U. Concomitant therapy included Benzamycin Topical Gel and Nuvaring. On 05-DEC-2006 the patient developed painful redness to her face one week after her first injection and on 13-MAR-2007 she also developed painful redness to her face one week after her second injection. The redness and pain lasted about a week and a half in both cases. The patient sought unspecified medical attention. The patient recovered. Additional information has been requested. In follow up it was reported that patient had facial erythema x 2-3 days after each injection (after dose one and two). It was "Painful, itchy and no treatment was given." In follow up it was reported that physician reported that patient after receiving her first and second dose of GARDASIL developed a rash on her face. The patient recovered on an unknown date. Additional information is not expected. This is in follow-up to report (s) previously submitted on 7/16/2007. Initial and follow up has been received from a licensed Practical Nurse (L.P.N.) and a physician concerning a 18 (previously reported as 17 year old)year old female who on 29-NOV-2006 was vaccinated into arm IM with a first dose of GARDASIL vaccine.
Soreness and swelling in arm. Fatigue for days, afterwards (1-2 months).
Pt began breathing hard, shaking, lost breath began to turn blue; Taken to ER seen by MD; No meds given says either sz or rxn to shot;
Severe itching, hives with wheals, erythema reaction treated with Benadryl. Hives improved: pt sent home after 1.5 hour observation with prescription of Benedryl and Prednisone.
one week after injection, injection site became inflamed, this went away in a few days.  however, fingers and toes became very red and itchy that same day & has not gone away yet (3 weeks). also developed red itchy bumps on right side beneath under arm.
Patient experienced right leg pain and numbness, to extent that he is having trouble walking; also has had some nausea and vomiting.  Symptoms began 30 min after receiving the vaccine.
very fatigued after 2nd dose, for about a week; This is a spontaneous report from a non-contactable consumer or other non HCP.   A adult male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot number: not reported) on an unspecified date for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown If patient received other vaccine in four weeks. The patient experienced very fatigued after 2nd dose, for about a week on an unspecified date. It was unknown if the patient was diagnosed Prior and post to vaccination, with COVID-19. Patient did not received any treatment for the event. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
2 1/4" x 2 1/4" localized rxn on lt thigh noted 6FEB92 p/DTP given 5FEB92;  f/u visit 7FEB92 much improved;
On the second day of 3rd dose patient complains of pain in the neck. at the third day the patient state that she had pain in the area and itchy.
Sore/pain/stiffness..loss of mobility.  Pain and unable to move arm still occuring on Jan 7, 2013.  Limited movement still.  Have been to doctor 3 times.  Given anti-inflammatory, prednisone and finally cortisone shot in shoulder rotator cuff area.  Pain has spread from upper arm to shoulder, upper back and neck.  Tingling down arm to fingers and hand. Hardness around injection site.
This spontaneous report was received from a currently 68 year old female patient reporting on herself. The patient did not have concurrent conditions, medical history, drug reactions or allergies. On an unspecified date in 2012 at the age of 65 years, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route, dose number, anatomical place of vaccination, lot # and expiration date were not reported). The patient was not taking any concomitant medication. On unspecified dates since vaccination with PNEUMOVAX 23 the patient reported to had developed 4 episodes of pneumonia. The patient reported that for the last episode of pneumonia she sought for medical attention and this one was confirmed by an X-ray on 01-MAR-2016. The patient started treatment with unspecified steroids and antibiotic. At the time of the report, the outcome of pneumonia was reported as recovering. The reporter did not provide a causality assessment between PNEUMOVAX 23 and the pneumonia. Additional information has been requested.
Headache; body aches; 102 temp; Chills; Sweating; food has no taste; tired/can't sleep; nauseous; tired/can't sleep; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0172) via an unspecified route of administration on the left arm on 30Apr2021 at 14:00(at the age of 57-year-old) as a single dose for COVID-19 immunisation. The medical history included basal cell skin cancer. 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. The concomitant medications included varenicline tartrate (CHANTIX), rosuvastatin (ROSUVASTAT) and topiramate (MANUFACTURER UNKNOWN), all from unknown dates and for unknown indications. The patient previously took sulfur(MANUFACTURER UNKNOWN) and experienced allergy. On 30Apr2021 at 19:30, the patient experienced headache, body aches, 102 temp, chills, sweating, food had no taste, tired/can't sleep and nauseous. On 30Apr2021, the patient underwent body temperature test and the result was 102(unspecified units). The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, body aches, 102 temp, chills, sweating, food has no taste, tired/can't sleep and nauseous was recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Information has been received from a Registered Nurse concerning an 18 year old female patient with no pertinent medical history or drug reactions or allergies who on 01-SEP-1998 was vaccinated with VARIVAX (Oka/Merck) (Lot # 626959/0846H).  Concomitant therapy included ENGERIX-B.  Subsequently, laboratory data revealed the patient had a low VARICELLA titer.  The patient sought medical attention office visit.  Additional information has been requested.
My face looked like I had drawn on it with a dark blue pen. The veins on my face were extremely noticeable. From the top of my face around the sides, down the cheeks to the jawline. It looked like something was terribly wrong with my face. The veins were not raised.
Small area below my right knee, my right knee and entire right thigh swelled up. The area below my knee, my knee, and just above  my knee did not swell as badly as after the first vaccination but the swelling lasted longer than after the first.  The swelling started suddenly the day after the vaccination (3/25/21) and lasted at the same level through 4/18/21; however, the reduced knee flexibility that occurred because of the swelling  may not have resolved. The area effected is the same area where I had post-op infection in 1978 and nowhere else.  I am still having a lot of problems with the knee and thigh muscles but that might or might not be directly due to the vaccine because every time something affects that area, it seems to take longer to get the muscles built back up.
No additional AE/PQC reported; GARDASIL 9 that was administered after a temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 28-OCT-2020, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml, lot # S023475 with expiration date on 26-MAR-2022 (route of administration was not reported) for prophylaxis. No additional adverse event was reported. Administered dose of vaccine experienced the temperature excursion of 46.9 degrees Fahrenheit for 30 minutes twice, of 47.4 degrees Fahrenheit for 5 minutes and 46.2 degrees Fahrenheit for 1 hour 10 minutes. Digital data logger was involved and there was no previous temperature excursion. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S023475; expirationdate: 26-MAR-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
No adverse event; Patient received 0.15ml doses of the Moderna COVID19 vaccine instead of 0.25ml doses/ Incorrectly drawled up the doses; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.15ml doses of the Moderna COVID19 vaccine instead of 0.25ml doses/ Incorrectly drawled up the doses ) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .15 milliliter. On 16-Aug-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.15ml doses of the Moderna COVID19 vaccine instead of 0.25ml doses/ Incorrectly drawled up the doses ). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.15ml doses of the Moderna COVID19 vaccine instead of 0.25ml doses/ Incorrectly drawled up the doses ) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient received 0.15ml doses of the Moderna COVID19 vaccine instead of 0.25ml doses/ Incorrectly drawled up the doses ).    No concomitant medications were reported.  The patient received lower than authorized doses and received 0.15ml doses of the Moderna COVID-19 vaccine instead of 0.25ml dose. The reporter had an issue and they incorrectly drawled up the doses.  No treatment information was provided by the reporter.
Fever; chills; shaking; cold; sweating; no appetite; exhaustion; sore throat; lung pain; burning sensation; shooting pain; nightmares; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 26Mar2021 at 16:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included allergic asthma and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have a history of allergies to medications, food or other products. Concomitant medications included paracetamol (TYLENOL) for an unknown indication from an unknown date. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 05Mar2021 at 17:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. On 27Mar2021 at 11:00, the patient experienced fever 102.5 (unspecified units), chills/shaking, cold, sweating, no appetite, exhaustion, sore throat, lung pain (burning sensation and shooting pain) and nightmares. Therapeutic measures were not taken as a result of the events. The events 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 outcomes of the events fever 102.5, chills/shaking, cold, sweating, no appetite, exhaustion, sore throat, lung pain (burning sensation and shooting pain) and nightmares was recovered in 2021.   No follow-up attempts are needed. No further information is expected.
almost died as a result of getting the Pfizer vaccine; The patient had a severe allergic reaction; blood pressure to severely drop and at 1 point was 73/35.; heart damage; cardiac enzymes to increase; 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 63-year-old patient received bnt162b2 (BNT162B2), administration date 06Dec2021 (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: NEAR DEATH EXPERIENCE (hospitalization, medically significant, life threatening), outcome "unknown", described as "almost died as a result of getting the Pfizer vaccine"; HYPERSENSITIVITY (hospitalization), outcome "unknown", described as "The patient had a severe allergic reaction"; BLOOD PRESSURE DECREASED (hospitalization), outcome "unknown", described as "blood pressure to severely drop and at 1 point was 73/35."; MYOCARDIAL INJURY (hospitalization), outcome "unknown", described as "heart damage"; MYOCARDIAL NECROSIS MARKER INCREASED (hospitalization), outcome "unknown", described as "cardiac enzymes to increase". The patient was hospitalized for near death experience, hypersensitivity, blood pressure decreased, myocardial necrosis marker increased (hospitalization duration: 5 day(s)); the patient was hospitalized for myocardial injury (hospitalization duration: 5 day(s)). The events "almost died as a result of getting the pfizer vaccine", "the patient had a severe allergic reaction", "blood pressure to severely drop and at 1 point was 73/35.", "heart damage" and "cardiac enzymes to increase" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: 73/35; myocardial necrosis marker: increased. The patient had a severe allergic reaction and almost died as a result of getting the Pfizer vaccine. The Pfizer shot caused the patient's blood pressure to severely drop and at 1 point was 73/35. The patient's doctor's office had to call and the patient was admitted to the hospital for 5 days. Turned out, the Pfizer shot had caused heart damage and the patient had to have a cardiac cath. The vaccine also caused cardiac enzymes to increase. The patient almost died.  The lot number for bnt162b2 was not provided and will be requested during follow up.
No adverse effects. Vaccine was given before child was 5 years old. She received a second dose on 12/2/2021 before this was noticed. Parents gave us a birthdate at both appointments which would have made her 5 years old for both vaccines. Error was detected by in database.
p/vax exp 60-75 chickenpox lesions over entire body;seen in MD office on 12/7/98;
Pt rec'd AFLURIA vaccine about 1615. At approx 1930 pt started to have fever & chills. Nausea & headache. Fever was 103.5. Fever, chills, headache lasted over 24 hours. Next 24 hours pt experienced chills & overall body weakness.
ADMINISTRATION ERROR ( WAS GIVEN A MONOVALENT PFIZER VACCINE for BOOSTER)
Patient passed out, momentarily had trouble breathing. Pt recovered, no Epi or Benadryl needed.
pt exp pain @ the time of flu vax;that evening pain worsened & swelling devel @ the inj site;the next day site was very itchy;this event had mostly resolved @ the date of this report;
Began to ache from my jawline down to my feet.  Aching increasing became worse until I could barely turn over in bed or sleep properly - almost shooting pain primarily in the neck, back and hips. Also got the chills during the night and had to wrap up in a blanket for several hours until I could get warm.  The next morning (today), aching continues although I am able to function.  Also had diarrhea today.
Case of shingles, chills, uncontrolled  blood pressure super high top and bottom numbers blood pressure pills not working more then 8 weeks after the shots . Blood pressure was fine and controlled before shot
MOC noticed rash on right lateral thigh  Getting bigger according to MOC  Flat, well demarcated, oval, red lesion to R lateral thigh (5cm X 3.5 cm), warm  Treatment options included in plan of care include cold compress and ibuprofen PRN
face is swollen; This is a spontaneous report from a Pfizer-sponsored program,Support from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 23Feb2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had the shot on 23Feb2021, then her face was swollen on an unspecified date. Her 2nd dose is on 15Mar2021 and wanted to know how to make her swollen face go down. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Allergic: Rash Generalized-Medium, Additional Details: pt had full body rash
103 fever starting at 1800 on 1/26 until 2000 on 1/27 101 fever starting at 2000 on 1/27 until 0600 on 1/28 extreme body aches and chills starting at 1600 on 1/26 until 0600 on 1/28 extreme headache stating at 1800 on 1/28 that is still ongoing (1/28, 1200) vomiting x1 around 2100 on 1/26
pt recv vax & w/in 12hrs exp a sz;pt was taken to ER where was treated & released;pt recovered
pt recv vax 7APR97 & around 2PM father stated that child had high fever then had convuls lasting less then one minute @ 7APR97 around 1130PM;pt seen today;
Information has been received from a pharmacist concerning a male who on approximately 28-AUG-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  In August 2007, shortly after vaccination a PT-INR laboratory test showed an increase (11.1).  A product quality complaint was not involved.  Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of CUTANEOUS VASCULITIS (looked like Leukocytoclastic vasculitis) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Leukocytoclastic vasculitis (had that earlier couple years ago after I came back from vacation but it was on both the legs). Concurrent medical conditions included Migraine. On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced INSOMNIA (didn't sleep all night), NAUSEA (nauseous) and VACCINATION SITE PAIN (injection site pain). On 02-May-2021, the patient experienced MIGRAINE (migraine), MALAISE (Not feeling great), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills). On 03-May-2021, the patient experienced CUTANEOUS VASCULITIS (looked like Leukocytoclastic vasculitis) (seriousness criterion medically significant), PRURITUS (leg were itching) and RASH (had little red dots everywhere on right legs). On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (Vaccination site hemorrhage), VACCINATION SITE BRUISING (Vaccination site bruising) and VACCINATION SITE SWELLING (Vaccination site swelling). At the time of the report, CUTANEOUS VASCULITIS (looked like Leukocytoclastic vasculitis), INSOMNIA (didn't sleep all night), MIGRAINE (migraine), PRURITUS (leg were itching), MALAISE (Not feeling great), VACCINATION SITE HAEMORRHAGE (Vaccination site hemorrhage), VACCINATION SITE BRUISING (Vaccination site bruising), RASH (had little red dots everywhere on right legs), FATIGUE (fatigue), PYREXIA (fever), CHILLS (chills), NAUSEA (nauseous), VACCINATION SITE PAIN (injection site pain) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.9 (Inconclusive) 99.9. No relevant concomitant medications were reported. Treatment for the events included acetaminophen, Excedrin and ice pack. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-114413 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt exp a systemic rxn similar to that of a friends (WAES 91051026) who devel fever, diarrhea, achiness, & a sore thorat following vax w/Hep B vax;
ALTERED MENTAL STATUS Bradycardia Elevated troponin Non-traumatic rhabdomyolysis Death
No additional AEs; temperature excursion; This spontaneous report was received from a registered nurse and refers to a 6-month-old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 06-DEC-2022, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1892790, expiration date: 03-DEC-2023, administered orally for prophylaxis (strength and dose were not provided); diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, lot #U7205AA, expiration date: 23-OCT-2024, administered intramuscularly for prophylaxis (strength and dose were not provided); and pneumococcal vaccine conj (PCV 13) lot #FN5555, expiration date: 31-JUL-2024, administered intramuscularly (strength, dose, formulation, and indication were not provided) (product storage error).  On an unknown date, before the administration, the vaccines underwent temperature excursion for unknown period of time. There was no adverse event reported.  The reporter considered temperature excursion to be not related to suspect vaccines.; Sender's Comments:  US-009507513-2212USA007828: US-009507513-2212USA007829: US-009507513-2212USA007830: US-009507513-2212USA007831: US-009507513-2212USA007832: US-009507513-2212USA007833: US-009507513-2212USA007834: US-009507513-2212USA007835: US-009507513-2212USA007836: US-009507513-2212USA007837: US-009507513-2212USA007838: