chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route, and lot were not reported). On an unknown date, the patients received improperly stored RECOMBIVAX HB. No adverse symptoms reported. At the time of the report the action taken was not reported. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information was received from a registered nurse concerning a 1 day ale patient. Patient's birth weight was 6 lbs 4 oz with 4 siblings. Patient was vaccinated with RECOMBIVAX HB the same day that he was born (21-MAY-2014) at 19:56 PM. Lot  number J012520; Exp. Date: 30-JAN-2016. The vaccine storage temp dropped to 0-1 degrees on 18 different episodes between May 14th and July 21st (unspecified year) according to min/max. All recorded temperatures are within 2-8 degrees. Additional information is not expected since all follow ups requested to complete the case were received.
I had fatigue, headache, and pain at injection site.  Then two later, I had major fatigue, dizziness, and tired. I was serve nausea, headache, and head pressure.  I am very weak and shaky.  These symptoms have lasted for about 2 weeks.  I went to my doctor and a hospital.  The hospital did a bunch of blood work. They could not found anything wrong.
I started to develop difficulty in breathing just while speaking. It happens at random times of the day and I have  had my second COVID vaccine, Moderna Lot#001A21A  and the severity of the shortness of breath is worse.  I have never had shortness of breath for any reason.  I do cardio fitness routines and never have shortness of breath, this has just begun since my first vaccine and I would really like to know if this is a normal reaction and whether it would be expected to go away!
3.5" diameter X 3" swollen/red area. Slight bruise in center. Afebrile.  No acute distress (R) thigh - KINRIX.
fever, achy, chills..... day 2, day 3 and day 4
Mother noticed hard bright red lump on Left arm, she said that it was the size of a baseball, hard, red and hot. Noticed it 2 days after Immunizations, son had not complained. Reported it to Health Department 5 days after Immunizations. At this time size and warmth are the same but it is now pink instead of bright red.
Information has been received from a nurse concerning her 17 year old daughter with cystic acne, warts on her right lower leg and no known allergies/drug reaction who on 20-AUG-2007 was vaccinated intramuscularly(site not reported) with the 1st 0.5ml dose of GARDASIL(lot# not reported). On 17-OCT-2007, the patient was vaccinated intramuscularly(site not reported) with the 2nd 0.5ml dose of GARDASIL (lot# not reported). Concomitant therapy included YAZ. The nurse reported that her daughter experienced an increase in the number and size of pre-existing warts on her right lower leg 2 weeks post the 2nd vaccination. The patient also developed several warts on her face. The patient was evaluated by her dermatologist, who performed a biopsy on the lesions on 28-NOV-2007. The results of the biopsy are pending. The patient has been scheduled for a allergy consult in the near future. The nurse added that her daughter was experiencing increased fatigue and hair thinning "for several months". The patient did received unspecified medical attention and Thyroid function test(normal) and a mononucleosis test (negative) were performed. At the time of this report the patient had not recovered. Additional information has been requested. Information has been received from a nurse and a nurse practitioner concerning the nurse's 17 year old daughter. A student, with cystic acne, warts on her right lower leg and no known allergies/drug reactions, who on 20-AUG-2007 was vaccinated intramuscularly in the left deltoid, with the first dose, 0.5ml, of HPV vaccine (lot # 0530U). On 17-OCT-2007, the patient was vaccinated intramuscularly in the left deltoid, with the second dose, 0.5ml, of HPV vaccine (lot # 65453970242U). There was no illness at the time of vaccination. The nurse reported that her daughter experienced an increase in the number and size of pre-existing warts on her right lower leg, 2 weeks after the second vaccination. The patient also developed several warts on her face. The patient was evaluated by her dermatologist, who performed a biopsy on the lesions on 26-NOV-2007. The results of the biopsy are pending. The patient has been scheduled for an allergy consult in the near future. The nurse added that her daughter was experiencing increased fatigue and hair thinning "for several months". The nurse practitioner reported that the onset of all symptoms was in early November 2007. The patient received unspecified medical attention, and thryoid function tests and a monomnucleosis test were performed. At the time of this report the patient's symptoms were improving. Additional information has been requested. Follow-up information from the NP indicated that on 22-FEB-2008, the patient was considered to be recovered from the events, and now vaccinated IM in the left deltoid with the third dose of GARDASIL (lot #655322/1211U). Additional information is not expected.
5th Anthrax shot rt upper arm-positive for erythema-round area of 2 1/2 x 2 1/2 cm, hard lump.
got both doses of the vaccine and got the shingles / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got both doses of the vaccine and got the shingles again. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
At 4 yr well visit had mild allergies and slightly dull (L) tympanic membrane. No antibiotic needed, just recheck 1 month. Had fever and < 5 min seizure that night.
severe stomach cramps; diarrhea; She did get it eventually on Thursday, 20May2021; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (severe stomach cramps), DIARRHEA (diarrhea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She did get it eventually on Thursday, 20May2021) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A and 038AZ1A) for COVID-19 vaccination.     Concomitant products included VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She did get it eventually on Thursday, 20May2021). On 22-May-2021, the patient experienced ABDOMINAL PAIN UPPER (severe stomach cramps) and DIARRHEA (diarrhea). At the time of the report, ABDOMINAL PAIN UPPER (severe stomach cramps), DIARRHEA (diarrhea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She did get it eventually on Thursday, 20May2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information  included hydrated with Water and Gatorade.
The patient was scheduled to receive the BiValent booster however received the Monovalent in error
10 mn post vaccination pt complains of heaviness to the (L) arm. Was assessed by EMS. Vital stable 118/56 - 120/80 P88 O2 sat 100%. Was picked at 1225PM and transported to Hosp.
He was fine until 2/22/2021. He suddenly started having left leg weakness. He started becoming more dizzy next day and skipped his daily walk.  On 2/25/2021, his left leg weakness became worse. His wife gave him cane and took him to PCP who diagnosed him with BPPV and gave him meclizine.  Next day, he started having jaw stiffness and had difficulty in brushing his teeth.  He was complaining of blurry vision in both eyes.  He denied any double vision.  He stated he could not read things which he was able to read 2 days ago.  A day before he presented to Hospital, he was not able to walk at all and he required walker.  According to his wife, when she went to see him at Hospital around 7 PM on 03/05/2021, his oxygen saturation dropped twice and internist decided to transfer him to ICU. Later on, the decision was made to transfer him to Medical Center.  Pt was intubated, developed diffuse segmental myoclonus, required intense sedation; /ivig ineffective, now giving plasmapheresis.  pt underwent imaging of CNS, LP and extensive laboratory testing.
Information has been received from a registered nurse concerning a six year-old white male patient with reactive airway disease and allergies (date of onset unknown) who on 26-Aug-1998 was vaccinated with a dose of varicella virus vaccine live (Lot #624722/1325E). Concomitant vaccines administered on 26-Aug-1998 included a fourth dose of HIB conj vaccine (CRM 197) (HIBTITER) (lot number M195RF), and a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Lot #625227/159E). The registered nurse reported that the patient experienced breakthrough chickenpox after receiving varicella virus vaccine live. Additional information from the registered nurse indicated that the event onset was on 31-Oct-2003 at an unknown time. She also indicated the patient was seen on the day number three (03-Nov-2003) after the first eruption with vesicular lesions all over his trunk and scalp. The nurse reported the patient did not have a tympanic temperature or upper respiratory symptoms, but he did complain of some stomach ache and had some diarrhea on day number one, as well as "LL pain" times 2-3 hours, and itching. The registered nurse reported there were no laboratory or diagnostic tests performed, and the patient had no known reactions from prior vaccinations. It is unknown as to whether the patient was ill at the time of vaccination. The patient recovered, however the exact date of recovery is unknown. The registered nurse reported, "she does not really have any additional information". There was no product quality complaint reported. Unspecified medical attention was sought. The registered nurse also mentioned that several pediatric patients also had a similar experience following vaccination with varicella virus vaccine live. No additional information is expected.
Child had hives next morning, around neck, creases of arms and legs, around waist, under arm. Was seen by MD that day given Benadryl, was fine after 1 dose of Benadryl. No temp or diff breathing.
Exhaustion; Racing heart; Sore arm at injection site; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the right arm on 03Sep2021 at 15:15 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. The medical history included herniated disc. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. The concomitant medications included gabapentin (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN), duloxetine hydrochloride (CYMBALTA), magnesium/ potassium (MANUFACTURER UNKNOWN) and calcium (MANUFACTURER UNKNOWN); all taken for an unknown indication from an unknown date and unknown if ongoing. On 03Sep2021, the patient experienced exhaustion, racing heart and sore arm at injection site. The 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. Therapeutic measures were not taken as the result of the events. The clinical outcome of the events exhaustion, racing heart and sore arm at injection site was not resolved at the time of report.
After receiving Gardasil vaccine pt felt dizzy/faint - placed in supine position. B/P and pulse monitored and doctor examined pt. Sent home after B/P ok and pt. improved
Patient has been having abdominal pain x 3 months. Mom thinks it might be the HPV vaccine.
no adverse event; temperature excursion for GARDASIL 9 that was administered; This spontaneous report was received from a nurse practitioner, concerning a 13-year-old patient of unknown gender. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not reported.  On 06-AUG-2020, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter, as prophylaxis (frequency, route of administration, and anatomical location were not reported; lot number S020254 has been verified to be a valid lot number with expiration date reported and validated as 09-DEC-2021) which experienced a temperature excursion (product storage error).  On 12-AUG-2020, it was noted that the administered dose of vaccine experienced temperature of 11.2 degrees Celsius for 75 hours and 17 minutes on an unknown date. It was not reported if data logger was involved. No additional adverse event. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); devicelotnumber: S020254; expirationdate: 09-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Pre-filled syringes sent in the wrong needle. Dose must be administered intramuscular and dose was administered via subcutaneous needle.
A lump, bruising, warmth, itching, swelling, redness. Treatment includes Diphenhydramine HCL (25mg) and 1% hydrocortisone ointment.
Severe joint pain and low grade temp of 99.1F, took Motrin and Tylenol for over 24 hr time period as well. Letheragic for over 24hr time period, no illness prior to taking vaccine.
I was just going in to get a mole check and there was an area on my body that the skin looked different so she performed a biopsy where I was diagnosed with Lichen Sclerosus. I was prescribed Clobetasol Proprionate Ointment.
lt arm peripheral sensory neuropathy >90% resolved by 10 days post vax & cont to improve;
headaches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP),.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300034302 Same reporter/ drug/ event for different patients;
Didn't feel well; This is a spontaneous report from a contactable reporter (consumer or other non-hcp).  A child male patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), administration date an unknown date in 2021 (Lot number: unknown) as dose 2 (tris), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: Unknown; Route of Administration: Unspecified), for COVID-19 immunisation. The following information was reported: MALAISE (non-serious) with onset 18Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Didn't feel well".  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a consumer refers to a 76 year old female patient with high blood pressure, thyroid problems and penicillin allergy. The patient had shingles on an unspecified date years ago. In 2009 patient was vaccinated with ZOSTAVAX (1 dose, subcutaneous), because she thought it would prevent the shingles from happening again. Concomitant therapies included SYNTHROID and doxycycline (manufacturer unknown). On 07-MAR-2014 the patient experienced a case of shingles. She developed pain on her neck but did not have blisters. Her skin became sensitive and developed a rash on her neck. She was then prescribed NEURONTIN and VALTREX (dosage/frequencies unknown) and she feels much better now. The outcome of a case of shingles was reported as recovering. The patient sought medical attention by seeing her doctor; no lab diagnostic studies were performed. Additional information is not expected.
haven't been able to work; blood pressure was out of control/high blood pressure; wasn't able to exercise and everything went alive at the beginning of February; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (blood pressure was out of control/high blood pressure) and MALAISE (haven't been able to work) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL DIHYDRATE (LIZINOPRIL), AMLODIPINE BESILATE (NORVASC), PROPRANOLOL HYDROCHLORIDE, PRAVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), FISH OIL, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET), ARGININE (L ARGININE [ARGININE]) and ASCORBIC ACID, BETA VULGARIS ROOT, IRON AMINO ACID CHELATE, ROSA CANINA FRUIT, RUBUS IDAEUS LEAF (IRON SUPPLEMENT WITH VIT C & HERBS) for an unknown indication.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (blood pressure was out of control/high blood pressure) (seriousness criterion hospitalization), MALAISE (haven't been able to work) (seriousness criterion hospitalization) and EXERCISE TOLERANCE DECREASED (wasn't able to exercise and everything went alive at the beginning of February). The patient was hospitalized from 18-Jan-2021 to 21-Jan-2021 due to HYPERTENSION. At the time of the report, HYPERTENSION (blood pressure was out of control/high blood pressure), MALAISE (haven't been able to work) and EXERCISE TOLERANCE DECREASED (wasn't able to exercise and everything went alive at the beginning of February) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, Blood pressure measurement: high (High) high. On 09-May-2021, Blood pressure measurement: high (High) 187/83 mmHg..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event include 25mg metoprolol extended release daily, 0.2 mg per day clonidine patch had to change once a week, Hydralazine 3 times a day, Clonidine and 0.1mg as needed for severe Hypertension.  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-2021-117046 (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.
This spontaneous report as received from a registered nurse refers to a 4 year old male patient with no illness at the time of vaccination and no pre-existing conditions or allergies. On 10-JUN-2013 the patient was vaccinated with a third dose of VARIVAX (Merck), (subcutaneous injection in the right arm, lot number: H018790, exp. date 15-OCT-2014). On 10-JUN-2013, the patient experienced 6.5 x 7.5 cm area of swelling, hot and red arm and the patient was fussy. At the time of report, the patient's outcome was unknown. The relatedness between the patient's events and the patient was fussy and VARIVAX (Merck) was not reported. Additional information has been requested.
The patient presents with weakness.  The onset was 1  weeks ago.  Risk factors consist of hypertension and HYPERLIPIDEMIA.  86-YEAR-OLD FEMALE PAST MEDICAL HISTORY HYPERTENSION, HYPERLIPIDEMIA PRESENTS WITH 1 WEEK HISTORY OF FEELING GENERALIZED WEAKNESS.  PATIENT STATES THAT A COUPLE WEEKS AGO SHE DID HAVE A RUNNY NOSE AND COUGH THAT HAS SINCE RESOLVED.  PATIENT IS FULLY VACCINATED FOR COVID-19 WITH PFIZER.  DENIES ANY ABDOMINAL PAIN, NAUSEA VOMITING DIARRHEA.  REPORTS SOME SHORTNESS OF BREATH..
Received the Vaccine (Unspecified Vaccine),contracted Covid after that; Received the Vaccine (Unspecified Vaccine),contracted Covid after that; This is a spontaneous report from a non-contactable healthcare professional (patient). A patient of unspecified age and gender received first single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine. Patient was a healthcare provider and then contracted Covid after that. Patient asked if she should still go ahead and still take the dose of the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible. Information about Lot/Batch cannot be obtained. No further information is expected; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.