chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient tested positive after 1st dose; Patient tested positive for Covid after 1st dose; This is a spontaneous report from a Pfizer-sponsored program.  A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, batch/lot number and expiration date not provided), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter has patient who had 1st dose of COVID vaccine on 13Jan and then tested positive for COVID. She is calling today because her patient is scheduled for her next dose on 15Feb and she wants to make sure that date is ok. The patient underwent lab tests and procedures which included tested positive for COVID on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of bnt162b2(COMIRNATY), on 13Jan2021, and COVID-19 test positive on an unspecified date.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like COVID infection date needed for a full meaningful medical assessment.
She told me her mouth hurt and was covering her ears. She continued to be in distress and I took her to the doctor on 06/30/2022. She diagnosed with Hand, Foot, and Mouth disease, she had multiple sores in her mouth, two on her hand and foot, and a few on her bottom. she was not prescribed any medication and I was told she can take Children's Motrin and Tylenol.
No adverse event; We had a patient that received Moderna Covid-19 Vaccine, Bivalent as the 1st dose of the primary series; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (We had a patient that received Moderna Covid-19 Vaccine, Bivalent as the 1st dose of the primary series) and NO ADVERSE EVENT (No adverse event) in a 30-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Nov-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (We had a patient that received Moderna Covid-19 Vaccine, Bivalent as the 1st dose of the primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (We had a patient that received Moderna Covid-19 Vaccine, Bivalent as the 1st dose of the primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (We had a patient that received Moderna Covid-19 Vaccine, Bivalent as the 1st dose of the primary series).    No Concomitant medications were provided. No treatment medications were provided.
Extreme breast tissue inflammation 11/7/2019 and 2/25/2020 along with psoriasis on breast skin and nipple
L SIDED BELLS PALSY, ONSET <24 HOURS AFTER VACCINE -           -prednisone, valacyclovir, doxycycline CELLULITIS
Injection site soreness (more so than Flu Vacc), overall fatigue, very mild headache. Tylenol taken at 2100hrs and feeling great at 0600 4/3/2021
Severe heart palpitations and shortness of breath. Heart monitor and cardiac MRI. Diagnosed with myocarditis. Treatment: colchicine and metoprolol succinate
Information has been received from a physician's assistant concerning her friend's child who in December 1995 was vaccinated with varicella vaccine. On 05/24/2002 the physician's assistant reported that the child "was vaccinated at the same time as her child and also has chicken pox currently." It was noted that the two children have had no recent contact. Unspecified medical attention was sought. No other info was available about this child. The physician's assistant's child had a similar experience after vaccination with varicella vaccine. Additional info is not expected.
The baby quit eating, was slightly dehydrated, weakness and very lethargic. Baby was taken to ER and admitted. IV fluids were given. Spinal tap, brain scan and blood work were neg. Transported to another facility. EMG showed a diagnosis of acute inflammatory axenal neuropathy. IVIG given.  Also diagnosed with thrush.
Patient stopped by the pharmacy on Monday, Feb 10 stating he had a lot of pain when he tried to raise his left arm.
Information has been received from Abbvie (15K-163-1357325-00) on 08-DEC-2015. Spontaneous report by a consumer of a 60 year old female with an event of non-serious shingles vaccine administered with HUMIRA. There was no reported medical history. On 02-MAR-2015, the patient experienced shingles vaccine administered. On 02-MAR-2015, the patient administered a shingles vaccine. Later that evening the physician contacted the patient and stated that she should not have received a live vaccine because she was on HUMIRA. The patient was prophylactically treated with valacyclovir HCL. The patient denied adverse reactions since received the vaccine. Shingles vaccine (Varicella Zoster Vaccine) was also considered a suspect. The primary reporter did not provide lot number information because the product packaging was not in her possession. The patient was treated with valacyclovir HCL. The reporter stated that there was no reasonable possibility that the event of shingles vaccine administered was related to HUMIRA. No follow up information available.
Excessive periods. I was in perimenopause with lighter/ cycles over past 4 yrs.  Since vaccination began, I have had cycles on 01Apr, 29Apr & 05Jun which were each heavier; This is a spontaneous report from a contactable consumer reporting for herself. A 48-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 intramuscular, administered in Arm Left on 09Apr2021 16:00 (Batch/Lot Number: EW0153; Expiration Date: 31Jul2021) as dose 2, single, dose 1 intramuscular, administered in Arm Left on 17Mar2021 17:30 (Batch/Lot Number: EN6204; Expiration Date: 30Jun2021) as dose 1, single (at the age of 48-years-old) for covid-19 immunization. Medical history included menopause from Mar2017 and ongoing. Concomitant medication included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) via unspecified route in arm as single dose taken for immunization in 03Mar2021. Historical vaccine included TDAP on 17May2011 + prior via unspecified route in arm for immunization. The patient did not have any known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Pertinent details included Monthly cycle slowing X 4years. In 2020 laveraged 5 cycles of lele days long. Last period before vaccine was 31Oct2020 and cycle lasted 152 days. It was reported that, excessive periods, she was in perimenopause with lighter/shorter cycles over past 4 yrs. No cycle at all in 5 months. Since vaccination began, she has had cycles on 01Apr2021, 29Apr2021 & 05Jun2021 which were each heavier than she had had in several years. Vaccine 1 on 17Mar2021 and Period on 01Apr2021 (28 days cycle), then Vaccine 2 on 09Apr2021 and Periods on 29Apr2021 (37 days cycle). Again period on 06May2021. This one was very heavy in first 24 hours heaviest she had in year. She had made it 5 months w/o menses before vaccine triggered monthly cycles. Saw primary care physician (PCP) on 16Jun2021 but symptoms had resolved. As of 25Jul2021 still waiting on next monthly cycle but hoping frequency resumes the prior normal length. The patient did not receive any treatment for adverse event. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
tested covid positive last week; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested covid positive last week) in a 58-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested covid positive last week). At the time of the report, COVID-19 (tested covid positive last week) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) positive.     The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided  It was reported that patient tested covid positive last week and he was doing well. He believed this was because moderna vaccine had trained his body so that it could put-up a good fight.   No treatment medications were provided.  Company comment: This is a spontaneous case concerning a 58-year-old male patient, with no reported medical history, who experienced the unexpected and non-serious AESI of COVID-19 after an unspecified dose of mRNA-1273 vaccine. The onset date of the event and the vaccination date were not reported; hence, latency could not be assessed. A positive SARS-CoV-2 test was performed on an unknown date. No information disclosed about clinical course, other lab tests or treatments received. At the moment of report the outcome of the event was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Upon internal review on 26-Sep-2022, significant correction was performed to update Patient country, height, obtain drug country and drug authorization country of suspect vaccine, reporter and causality and Narrative. Sender's Comments: This is a spontaneous case concerning a 58-year-old male patient, with no reported medical history, who experienced the unexpected and non-serious AESI of COVID-19 after an unspecified dose of mRNA-1273 vaccine. The onset date of the event and the vaccination date were not reported; hence, latency could not be assessed. A positive SARS-CoV-2 test was performed on an unknown date. No information disclosed about clinical course, other lab tests or treatments received. At the moment of report the outcome of the event was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
staff member administered FLUZONE HIGH-DOSE QIV to a patient that is 60 years of age with no reported adverse event.; Initial information was received on 17-Nov-2022 regarding an unsolicited valid non-serious case from an other health professional.  This case involves a staff member administered influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] to a 60 years old female patient with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Nov-2022, staff member administered dose of 0.7 ml once suspect influenza quadrival A-B high dose HV vaccine (lot number: UT7733BA, expiry date, formulation: Unknown) via intramuscular route in the left deltoid for Immunisation to a patient that is 60 years of age with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  No lab data reported.  Action taken: not applicable.  Outcome: Unknown for the event staff member administered fluzone high-dose qiv to a patient that is 60 years of age with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
extreme pain in both feet, , lumbar spine region; servere icy cold feeling, burning and tingling sensations in all body parts described above.
Patient was injected with the (0.5ml) incorrect volume and should of been injected 1ml.  Patient returned to receive the other 0.5ml the same day.
Pt was approximately 2 weeks pregnant at time of MMR vaccination. Pt stated she was not pregnant at that time. Pt discovered she was pregnant on 2/28/2000 at 14:30.
Pt stated left posterior neck mass occurred after receiving vaccine - CT - done 8-10-09 findings left posterior neck 6.5cm superficial lipoma.
7MAR96 lt arm began itching & burning-pt noticed small red area about size of quarter;soreness minimal itching,redness,& swelling cont on 11MAR96 saw MD which noted 10 1/2 cm by 11 1/2cm erythema w/firmness & contacted hlth dept;
Information has been received from a registered nurse concerning a now 24 months old male who in October 2008, at the age of "15 months old" was vaccinated with MMR II and VARIVAX. Apparently within 24 hours of receiving both vaccinations, the patient developed a decreasing ability to speak. Unspecified medical attention was sought. At the time of the report, the patient had not improved. The decreasing ability to speak was considered to be disabling. Additional information has been requested.
Client 20 years old given MMRV instead of separate MMR and Varicella vaccines. No treatment required.
Patient reports itchy throat after flu shot given. Patient given BENADRYL 50 mg p.o. now. Patient to wait in the lobby for at least 30 minutes to see if this improves. Patient to take BENADRYL at time Q. 6 hours at home today. No throat swelling, erythema, rash, or difficulty breathing noted. Reports a chest cold guarded last week. Has some congestion type pressure in her chest. Diphenhydramine 25 MG QID.
None Stated Autopsy Report received 3/16/06 revealed COD as bronchopneumonia.
Patient stated she had blurred vision. Her pupils were dilated, she felt dizzy and then nauseous. We offered water and a Dramamine chewable. She became pale and her pulse was hard to feel. We took her blood pressure, it was 88/43 mmHg. We called the supervising physician, the doctor and EMS.
Pt recv vax & 06May97 lab eval revealed "failure to seroconvert".
Product storage error; no adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event) in an adult male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 03-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medications were reported.  Dose of Monovalent vaccine which was expired on 26-Feb-2023, was administered to the patient. There were 1 dose 4 of unknown size vial was there. The vial was initially stored in the refrigerator on 03-Mar-2023. The vial did not undergo any temperature excursions.  No treatment details were reported.
After the shot, my arm was swollen for 3 days and a small rash but it went away. Then, on Feb 13th a rash started to reappear that was warm to the touch and itchy and burning. I applied cortisone but rash on injection site kept growing. On Feb 14th, I woke up and rash was a bit smaller but every two hours I would have a tingling sensation like when your foot falls asleep but it went up my shoulder and back area up to my neck and occurred every 2 hours. I then was advised to take claratin, add more cortisone, and take Benadryl as well. The itchiness stoped. My rash is still there but it?s very light compared to feb 13th.
Pt recvd vax @ 1PM & becam unresponsive diaphoretic, hypotensive, some twitching noted @ onset of sx; Epi given;
unaware if any of the products with temperature excursion were administered; unaware if any of the products with temperature excursion were administered; This non-valid spontaneous report was received from a medical assistant referring to unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided.  Since 19-JUN-2020, patients might be vaccinated with improperly stored doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R032768 (expiring on 31-AUG-2021) and lot # R024272 (expiring on 28-MAY-2021), or, pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T009743 (expiring on 27-JAN-2022), or, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1660693 (expiring on 19-MAR-2021), or, haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # S008730 (expiring on 23-JAN-2022).  For all the vaccines, indication was prophylaxis, dose, route and site of administration were not reported.  The administered doses of the vaccines experienced a temperature excursion above 47°F for 23 hours and 45 minutes, as recorded by a data logger. The vaccines had not had any previous temperature excursions.  The medical assistant was unaware if any of the products involved were administered.  This case was considered non-valid due to lack of individual patients' identifiers.
Read the first section. We cannot get a treatment plan because we cannot get a diagnosis! NONE of this crap happened until the GARDASIL shot was received! Specifically the third and final dose.
the patient's arm was painful and warm to touch; the patient's arm was painful and warm to touch; the patient's arm, where she vaccinated with Pneumovax 23, swelled up at the injection site and further down her arm; the patient's arm, where she vaccinated with Pneumovax 23, swelled up at the injection site and further down her arm; This spontaneous report as received from a medical assistant refers to a 71-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. Concomitant therapies included amlodipine, hydrocodone, clotrimazole cream, triamcinolone cream and albuterol (VENTOLIN) inhalation as needed. On 25-OCT-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, intramuscularly (lot # S018405, expiration date reported as 28-MAR-2021, but upon internal validation established as 23-MAR-2021) (exact dose and route of administration were not reported) for prophylaxis. On 25-OCT-2019, the patient's arm, where she was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), swelled up at the injection site and further down her arm. Additionally, the patient's arm was painful and warm to touch. The patient sought medical attention by visiting the office and received dexamethasone injection as a treatment. The outcome of injection site swelling, skin warm, pain in extremity and peripheral swelling was unknown. No causality assessment was provided by the reporter.
Information has been received from a registerd nurse concerning an 18 year old female who on 02-APR-1999 was vaccinated with PNEUMOVAX 23. That evening, the patient experienced chills. On 03-APR-1999 in the morning the patient experienced arm soreness, it hurt to use the arm. On 04-APR-1999 the patient experienced a fever of 101.7 degrees F. At 3:00 PM that day the patient experienced red patches 3 inches below the site of injection. She took ibuprofen and TYLENOL. She also experienced back, head, and neck soreness. On 04-APR-1999 the patient also experienced fever of 100.7 degrees and sore muscles. Her arm hurt from the shoulder down. On 05-APR-1999 the patient experienced redness and induration at the site of injection, nausea and pulse was 112. An EKG on 05-APR-1999 was normal. That afternoon, the patient's temperature was 102.7  degress F. and the soreness persisted. The patient receoverd from the red patches below the injection site on 05-APR-1999. At the time of the report, the patient has a fever of 99 degrees F. and the headaches and the arm pain persisted. Another patient was reported with adverse experiences following vaccination with PNEUMOVAX 23 (WAES 99040466). No further information is available.
About 30 minutes post vaccination I felt the left side of my face become tingly and then my nose tingled and felt stuffy for about 3 hours. At approximately 7PM that evening I started to feel chills  and  severe abdominal cramping/nausea/diarrhea for about 24 hours.-constant and then from 10/21/21 and including 10/25/21- I feet fatigue and multiple muscle and joint pains. I am currently feeling these symptoms.
Fully vaccinated for COVID patient who tested positive COVID test on 09/03/21 during routine screening for admission.  Patient asymptomatic.  Repeat testing on 09/03/21, 09/07/21, 09/09/21, and 09/10/21 all resulted as "Not Detected."  No symptoms of COVID during admission.
pain, swelling redness, hot, itchy started the next day persisted through 5/12/08 max size 10 cm x 16.5 cm
Delayed red warm rash on left arm around vaccination site with some mild pain that lasted around  4 days. It has since resolved.