chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received well child visit.  Received immunizations of Diphtheria, Tetanus, Pertussis, Poliomyelitis, Measles, Mumps and Rubella, on June 22, 2006 at approximately 2pm EST. Patient was on no medications, no past medical history other than speech delay, which referral to speech was given. His physical was, "Pass" with no restrictions.  On 1/11/2006, Patient was seen in a pediatric urgent care center at approx. 5pm for symptoms of Diabetes.  Patient was diagnosed with Type 1 insulin dependent diabetes on 1/12/2006 and started on subcutaneous insulin that same day.  Currently, patient remains on Sub Q insulin and is considered a brittle diabetic.  Patient is now six years old.  01/16/2008 Vax info obtained and updated in database. Date of vax was 2006, not 2005, per vax record. 01/18/2008 TC with mom to verify dates.  Confirmed vax date of 6/22/2006 and date of onset 1/2007 (not 2005 and 2006 as reported on VAERS form). Mom reports speech loss after 1st MMR and onset of diabetes 7 months after 2nd MMR in 6/2006. MR received for several OVs dated 1/12/2007, 2/15/2007 and 5/17/2007 with diagnosis new onset Type I Diabetes. Child developed increased thirst and urination following a febrile illness on 1/1/07. Pt was incontinent of urine and increasingly irritable. Seen in urgent care center with blood sugar of 365.   OV 2/15/07  doing well with glucose control. Skin dry with (+) eczema and skin reactions to insulin injections. 02/15/2008 TC from parent/reporter who reports pt became allergic to multiple insulins and developed Hashimoto's Thyroiditis following Varicella vax received on December 18,2007. This is a new development since original report.   02/15/2008 Vax and medical records recd from PCP showing WCC 12/18/07 with Varicella Vax (Merck 0720U) given.  OV 1/16/2008 due to allergy to insulin. Referred to Allergist.  OV 1/31/2008 due to anti-thyroid and anti-gliadin antibodies. Referred to endocrinologist. DX:  Thyroiditis and Celiac Disease. Referred to immunologist.  3/31/08 New VAERS report submitted 308413 by parent re: Varicella rxn. See 308413. 4/18/08 MR received from allergy/immunology consult from 1/17-2/14/2008 with DX:  Insulin Hypersensitivity, Recent h/o Hashimoto's Disease and Autoimmune Polyglandular Syndrome. Pt developed possible adverse reaction/allergy/hypersensitivity to insulin injections following Varicella vax.  Insulin injections sites with significant redness, swelling and induration, as well as facial redness. Pt also with recent increase in TSH from 1/10/08 to 1/18/2008.
21 y/o female who expressed significant anxiety prior to receiving the injection with no significant PMH who experienced immediate onset of right sided pleuritic chest pain across mid chest after receiving the injection into the left arm.  Felt dyspnea related to pain with breathing.  No itching, no urticaria, no angioedema, no wheezing, no GI or GU sx.  Vital signs with 100% O2 sat on RA, BP 124/77 HR 91 and RR 22.  Observed for 45 minutes without change/worsening of symptoms while awaited EMS arrival.  EMS took patient to the nearest emergency room for further evaluation and treatment.
No additional AE; 1 year old patient that received VAQTA, MMR-II, and VARIVAX on 12-JUL-2022 and received the VAQTA, MMR-II, and VARIVAX again on 26-JUL-2022.; This spontaneous report has been received from a nurse practitioner referring to a 1 year-old-patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 12-JUL-2022, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 mL intramuscularly, hepatitis a vaccine, inactivated varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 mL subcutaneously, and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 mL; all vaccines for prophylaxis(strengths, lot numbers, anatomical locations, routes of administration, and expirations dates were not provided).      On 26-JUL-2022, the patient received the second dose with hepatitis a vaccine, inactivated (VAQTA), 0.5 mL (lot number U012007 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 18-JAN-2023), hepatitis a vaccine, inactivated varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 mL (lot number T036561 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 28-OCT-2022) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) 0.5 mL (lot number T033814 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 05-OCT-2022); all vaccines for prophylaxis (strengths, anatomical locations, and routes of administration were not provided) (inappropriate schedule of vaccine administered). No adverse event was reported.
Client reports nausea, retching, extreme fatigue started 5 days after receiving the vaccine - symptoms continue - has been diagnosed with gastroparesis and is scheduled for treatment this week.
Sick and couldn't walk so missed second dose of vaccine; Sick and couldn't walk so missed second dose of vaccine; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 83-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 28May2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization (at the age of 83-years-old). The patient medical history and concomitant medications were not reported. It was reported that on 28May2021 the patient received the first dose of vaccine and stated that she was supposed to go to get her vaccine, but she was sick and couldn't walk on 18Jun2021, so missed second dose of vaccine. She called and they gave her another date. She can't remember the date when she was supposed to get the vaccine. She wanted to know if we could help her get the date. The outcome of the events was unknown.   Information about lot/batch number cannot be obtained.
flu like symptoms; This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. This pharmacist reported similar events for three patients. This is the third of three reports. A patient of unspecified age and gender received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiry date unknown), and influenza vaccine (FLU), both via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported that the patient experienced side effects from receiving pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) and flu together on an unspecified date. The patient experienced flu like symptoms for 2 days. The outcome of the event was unknown.  No follow up attempts are possible, information on the lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019438281 same reporter, same product, same event, and different patient;US-PFIZER INC-2019438279 same reporter, same product, same event, and different patient
Patient presented to the ED and was subsequently hospitalized for a small bowel obstruction within 6 weeks of receiving covid booster vaccination.
1/7: temp of 100, runny nose, sore arm and lymph node under armpit, headache  1/8: temp 99.6, headache, sore arm
Day after vaccine I noticed I could not hear the music at church very well. The next few days I felt as though I had fluid in my L ear. I noted a vibration in my ear when I coughed or cleared my throat.  Slightly dizzy.  Saw my ENT on Friday. He verified that there was no fluid in my L ear. Gave me a repeat hearing test and said I had significant decrease in hearing in my L ear compared to my previous test.  He ordered Steroids 40 mg BID for 7 days.  No improvement as of yet after 3 days.
Pt just got his + test for COVID-19 which were positive, pt has had some ? contacts at work, also he went to an Astros game where he may have been exposed; pt reports dry cough, mild malaise, denies any shortness of breath, no diarrhea, no changes in smell / taste.
Information has been received regarding a case in litigation from a registered nurse concerning a 9 year old female who on 25-SEP-2008 was vaccinated with a dose of VARIVAX (Oka/Merck) (injection site and route not reported). Subsequently the patient was diagnosed with shingles. The patient was receiving treatment from a physician. At time of this report, the patient was recovering from shingles. Additional information has been requested.
pt experienced weakness, nausea, and near syncopal episodes within 10 minutes of receiving vaccine. Symptoms resolved within minutes, pt was monitored in clinic for an additional 30 minutes with stable vitals and no further episodes. Pt left clinic in good condition, brother drover her home.
Prior to receiving injection, I consulted w/clinic staff  to determine whether the vaccine contains gelatin/ animal products due to alpha gal allergy.   It was determined that vaccine should be okay for me.  Within an hour of  receiving vaccination, red and warm area appeared; about 3 " across.  A few hours later,  it had doubled in size and was red, warm and itching.  I visited Occupational Medicine.  Given Allegra and ice pack, and left work early.  By evening, the area had spread further up/down (about 9 ") and around (about 8 ") upper arm; fingers were slightly numb  --felt like tourniquet at elbow. Took  Benadryl and marked perimeter of itching/redness.  In the  morning, the area had spread further down to my elbow and around upper arm.  It was still red, itching and warm.  My doctor's office had no appointments available and advised that I visit ER/Urgent care.   I went to local ER,  and was given prescription and first dose of Prednisone, Benadryl and Pepsid.  By the third day (10/12/19) the itching had stopped, and the redness was fading.
Bad bad Weakness in left arm as I couldn?t lift even a casserole dish and got a bad burn on my left arm Numbness and tingling in far left three digits  Pain for four months and off and on
Pt called reporting adverse reaction to HPV vaccine she received yesterday. Says her arm went completely numb immediately after the vaccine was given which she failed to report at the time. Says she went home and pain & numbness spread to her shoulder and back. She was seen at UC 10/25/19 and given prednisone & muscle relaxer which helped. I advised to continue monitoring and RTC or UC if symptoms persist beyond 3-5 days or worsen at any point. Says UC told her to check with us and see if our HPV vaccines are expired which they are not.
Admission Date: 6/23/2022 Discharge Date: 7/4/2022  PRESENTING PROBLEM: Acute respiratory failure with hypoxia (HCC) [J96.01] Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1]  Additional information for Item 18: HOSPITAL COURSE: Patient is a 85F with past medical history significant for PMR, vasculitis, giant cell arteritis, hx stroke, asthma who presented to the ER for hypoxia.   She was exposed to COVID this weekend by home caretaker. The day prior to arrival, she started to develop an occasional cough along with occasional nausea and vomiting.  She also reported fatigue and rhinorrhea. Earlier on day of admission, when her daughter went over to visit her, she noticed she was breathing faster and "didn't look right". Daughter had a pulse ox that she put on her and pt's SpO2 was at 80% on room air. Pt denied fever, chills, chest pain, lower extremity swelling, sore throat, abd pain. She has received the COVID vaccines.     Upon presentation to the ER, she was non-toxic appearing and saturating at 88% on room air. PCR confirmed that she had covid. Lab work was relatively unremarkable. CXR was reassuring and did not show evidence of pneumonia or infiltrate. She ultimately required 4L O2 and was then saturating well. She was also given dexamethasone 6mg IV. She was admitted to medicine in stable condition.    Overall, patient's respiratory status remained stable, with some mild respiratory distress, requiring up to 5L O2 via NC at rest. She was weaned down to room air  by discharge with respiratory status improved. She continued home asthma meds: symbicort BID, duo neb BID (albuterol inhaler ordered while inpatient to limit COVID aerosolization), additional albuterol PRN.  Started on mucinex BID, decadron 6mg daily x 10 days. Lovenox for VTE prevention. Patient/family declined remdesivir; Covid labs with lactic acid 1.9, d-dimer 690, CRP 23.7. Encouraged prone positioning, which patient was interested in and tolerated intermittently, along with frequent incentive spirometer use. Pt reported some coughing/choking with thin liquids on 6/24. Consulted Speech therapy and patient transitioned to nectar thick liquids (which she had been on in the past) with improvement. PT/OT were consulted and recommended discharge to SAR once out of COVID isolation.   For patient's chronic illnesses, she takes home daily predsione for her history of Giant cell arteritis, PMR, and vasculitis. This was held while on dexamethasone and resumed once complete. She continued her home oral Vit D 1000 units daily with home Ca-Vit additional supplements held (Ca level corrected for albumin near upper limit normal on labs and Vit D high at 71). Continued home PPI for GERD, as was as statin/Plavix for her history of stroke (2009)/hyperlipidemia and Zoloft for depression. She continued home vesicare for overactive bladder. No acute issues related to these
pt devel severe local rxn to lt arm w/puffiness, heat, throughout upper arm region-elbow to shoulder x 7 to 9 days;
pt recvd Engerix-B 29JUN91, 25JUL91, 23JAN92 & pt had lack of seroconversion (low titers-less than therapeutic);
Upper left arm with mild swelling, redness, no bruising, no induration or fluctuance. Painful.
sack of fluid on elbow; numbness feeling on left arm; soreness at injection site; bruise at injection site; difficulty lifting arm; rash on chest; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 6th July 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site bruising, injected limb mobility decreased and rash. On 9th July 2019, the patient experienced elbow bursitis and numbness of upper extremities. On 13th July 2019, the outcome of the injection site bruising, injected limb mobility decreased and rash were recovered/resolved. On 9th August 2019, the outcome of the elbow bursitis and numbness of upper extremities were recovered/resolved. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site bruising, injected limb mobility decreased, rash, elbow bursitis and numbness of upper extremities to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. The patient experienced difficulty lifting arm, rash on chest, sack of fluid on elbow and numbness feeling on left arm. The patient planned to follow up with his pharmacist on an unknown date. The reporter consented to follow up.
Pt developed generalized tonic clonic seizures at 2200 on 6/18/10. 911 was called and pt taked to Medical Center. He received multiple doses of IV Ativan (total 3 mg) was intubated for respiratory failure, still having seizures, recieved 15 mg/kg of phenobarbital, still seizing, recieved 15 mg Dilantin. Hospital transport team contancted, arrived on scene, administered another 5 mg/kg of phenobarbital. Pt was having generalized seizure for approximately 2 hours. Transferred to Pediatric Intensive Care unit intubated. Initial blood gas 6.9, pCo2 130, pt with Right main stem intubation, tube adjusted. Got CT of brain, ET tube came out, re-intubated and transported to another hospital. He was extubated on day 2 of hospitalization to room air. Neurology was consulted, pt had an EEG with generalized slowing after multiple drugs administered. MRI with small areas of periventricular white matter TR signal hyperintensity in bilateral occipital/frontal lobes, otherwise normal. Pt transferred to general hospital floor on day 2 of hospitalization, still very agitated with poor tone.
Tested positive for COVID-19; This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Patient Stated I have never tested positive. No concomitant medication were reported.  No treatment medication was reported. This case was linked to MOD-2021-276367 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Significant followup received contains dose 1 start date,anatomical location; Sender's Comments: This case concerns a 50years-old, female with no relevant medical history, who experienced the unexpected event of SARS-CoV-2 test positive. As per SD The event occurred  after being fully vaccinated with mRNA-1273 Moderna vaccine. (date of vaccination was not provided). The rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.
arm is red; arm is warm to the touch; sore arm; sore arm and a little swelling from Wednesday to Thursday; the arm got all swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (the arm got all swollen), ERYTHEMA (arm is red), FEELING HOT (arm is warm to the touch), PAIN IN EXTREMITY (sore arm) and PERIPHERAL SWELLING (sore arm and a little swelling from Wednesday to Thursday) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     Concurrent medical conditions included Tachycardia. Concomitant products included ATENOLOL for Tachycardia.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Aug-2021, the patient experienced PERIPHERAL SWELLING (the arm got all swollen). On 08-Sep-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and PERIPHERAL SWELLING (sore arm and a little swelling from Wednesday to Thursday). On 15-Sep-2021, the patient experienced ERYTHEMA (arm is red) and FEELING HOT (arm is warm to the touch). The patient was treated with PARACETAMOL (TYNELOL) on 16-Sep-2021 for Adverse event, at an unspecified dose and frequency. On 09-Sep-2021, PAIN IN EXTREMITY (sore arm) and PERIPHERAL SWELLING (sore arm and a little swelling from Wednesday to Thursday) had resolved. At the time of the report, PERIPHERAL SWELLING (the arm got all swollen), ERYTHEMA (arm is red) and FEELING HOT (arm is warm to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Received the second dose of vaccine after 35 days; 4th day she also had Covid arm/ a bruise of 4*3 inches; Hip pain/ joint pain; Couldn't  get out of bed during 16 days; Felt it  runaround her system/circulated all over body; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt it  runaround her system/circulated all over body), BACK PAIN (Back pain), CONTUSION (4th day she also had Covid arm/ a bruise of 4*3 inches), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose of vaccine after 35 days) and ARTHRALGIA (Hip pain/ joint pain) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter. .     On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced FEELING ABNORMAL (Felt it  runaround her system/circulated all over body), BACK PAIN (Back pain), ARTHRALGIA (Hip pain/ joint pain) and FATIGUE (Couldn't  get out of bed during 16 days). On 26-Mar-2021, the patient experienced CONTUSION (4th day she also had Covid arm/ a bruise of 4*3 inches). On 19-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose of vaccine after 35 days). The patient was treated with ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) at a dose of 1 dosage form. On 07-Apr-2021, FEELING ABNORMAL (Felt it  runaround her system/circulated all over body), BACK PAIN (Back pain), CONTUSION (4th day she also had Covid arm/ a bruise of 4*3 inches), ARTHRALGIA (Hip pain/ joint pain) and FATIGUE (Couldn't  get out of bed during 16 days) had resolved. On 19-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose of vaccine after 35 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.    This case was linked to MOD-2021-231551 (Patient Link).
Patient brought to Medical Center by ambulance.  Arrived at 11:30AM.  Received flu shot in school "earlier today" BP 111/83, Pulse 82, Resp 20, Temp 98.5 02 Sat 100% Patient presented with red face, c/o skin burning, headache Pt given "Benadryl PO" by school nurse prior to transfer. Pt given Prelone 15mg/5ml, 8ml po at 11:55AM Benadryl 5ml PO at 11:55AM, and Motrin 10ml PO at 12:55PM in the ER Pt discharged
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 10:00 as dose 5 (booster), single (Lot number: GH97034) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: GL8982), in left arm, on 04Feb2021 as dose 2, single (Lot number: En9581), in left arm, on 25Sep2021 as dose 3 (booster), single (Lot number: EW0187), in left arm and on 13Apr2022 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ACETAMINOPHEN, start date: 01Aug2022. The patient has no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Redness and discomfort at the site of the vaccination. Wheezing, headache, bleeding, cloudy mind.
2 days post vaccination, upper L arm (deltoid area) very red, painful, warm to touch.  Diagnosed as cellulitis and started on Augmentin.
DOSE 2 OF COVID 19 PFIZER VACCINE ADMINISTERED WAS 6 DAYS EXPIRED, NO ADVERSE EVENTS AS A RESULT
Pt recvd vax & 4 hrs later devel urticaria over the upper extremities, trunk, face & scalp;